Microplasty Total Knee Instrumentation...1 iroplasty ® Total Knee Instrumentation This...

Surgical Technique

Vanguard® Complete Knee System

Microplasty® Total Knee Instrumentation

Knees • Hips • Extremities • Cement and Accessories • PMI® • Trauma • Technology

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solution for each individual patient. This requires clinical

mastery, a human connection between the surgeon and the

patient, and the right tools for each situation.

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one surgeon and one patient. We treat every solution we

provide as if it’s meant for a family member.

Our approach to innovation creates real solutions that assist

each surgeon in the delivery of durable personalized care

to each patient, whether that solution requires a minimally

invasive surgical technique, advanced biomaterials or a

patient-matched implant.

When one surgeon connects with one patient to provide

personalized care, the promise of medicine is fulfilled.

One Surgeon. One Patient.®

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Contents

Introduction ..................................................................................................................................................................1

Patient Selection ..........................................................................................................................................................1

Preoperative Planning ..................................................................................................................................................2

Approaches ..................................................................................................................................................................3

Mini-medial Parapatellar Approach, Option 1 ..............................................................................................................4

Initial Skin Incision

Approach

Deep Exposure

Mid-vastus Approach, Option 2 ...................................................................................................................................5


Approach

Deep Exposure

Sub-vastus Approach, Option 3 ..................................................................................................................................7


Approach

Deep Exposure

Distal Femoral Resection .............................................................................................................................................9

Femoral Sizing ............................................................................................................................................................12

Adjustable Rotation Feet, Option 1

Fixed Rotation Feet, Option 2

Femoral 4-in-1 Resections .........................................................................................................................................14

PS Box Preparation ....................................................................................................................................................15

Universal Bone Conserving Guide

Tibial Resection ..........................................................................................................................................................18

Extramedullary Tibial Resection Guide

Tibial Sizing ................................................................................................................................................................21

Tibial Stem Preparation ..............................................................................................................................................22

I-beam Stem Punch

Patellar Resection ......................................................................................................................................................23

Surface Clamp

Patella Milling .............................................................................................................................................................24

Inset Single Peg Patella using the Vanguard® Patella Mill

Trial Reduction............................................................................................................................................................26


A


Tibial Implant Insertion ...............................................................................................................................................27

Femoral Implant Insertion ..........................................................................................................................................28

Patellar Implant Insertion ...........................................................................................................................................28

Locking Bar Insertion .................................................................................................................................................29

Instrumentation Layout ..............................................................................................................................................30

1


This Microplasty® Total Knee Instrumentation surgical technique is utilized by Keith Berend, M.D., Biomet as the manufacturer of this device, does not practice medicine and does not recommend this device or technique. Each surgeon is responsible for determining the appropriate device and technique to utilize on each individual patient.

IntroductionThe Vanguard® Knee System offers the flexibility to change from a cruciate retaining (CR) to a posterior stabilized (PS) or posterior stabilized constrained (PSC) knee within a single system. The transition between each constraint level can be made with ease, allowing the physician to evaluate soft tissue and bone deficiencies intraoperatively without making a preoperative commitment to the level of constraint.

Patient Selection Minimally invasive methods can be utilized on nearly all patients undergoing total knee arthroplasty. However, it is important to have adequate patellar mobility, which can be assessed on physical examination prior to making the skin incision, as well as intraoperatively. If multiple scars from previous surgeries exist, skin incision placement will need to be evaluated, as well as elements of scarring, which may decrease soft tissue mobility. If a high tibial osteotomy has been performed previously, a more traditional exposure is recommended, as this may require reconstructive methods which may be different from primary total knee replacement.

2

Preoperative PlanningIn order to assess bone stock, potential ligament instability and the anatomical axis, a 36" long standing A/P X-ray is recommended. Determine the angle between the anatomic and mechanical axis, assuring the distal femoral cut is perpendicular to the mechanical axis (Figure 1).

Estimate femoral component size preoperatively by using lateral view X-rays and radiographic templates. Confirmation of the appropriate size component intraoperatively is critical for normal kinematics.

Figure 1

3


ApproachesMicroplasty® Total Knee Instruments are designed for use with a minimally invasive technique. The instruments allow for minimization of the soft tissue trauma that occurs during total knee arthroplasty.

The skin incision can be significantly reduced in length (4–6"), and should be extended as required, depending on the clinical condition of the knee. However, it is critical to understand that the goal of a minimally invasive approach is not the length of skin incision, but rather reducing soft tissue trauma. This facilitates the early recovery of the quadriceps function and minimizes pain and swelling.

Three basic procedures can be utilized for minimally invasive total knee arthroplasty:

• Option 1: Mini-medial parapatellar (See page 4 for surgical technique)

• Option 2: Mid-vastus (See page 5 for surgical technique)

• Option 3: Sub-vastus (See page 7 for surgical technique)

The mini-medial parapatellar approach may be used initially. This approach can be easily extended or converted to a more extensive traditional approach, should additional exposure be necessary.

The mid-vastus approach can create extensive exposure without violating the quadriceps tendon with only a small split in the vastus medialis obliquus (VMO) muscle.

The sub-vastus approach preserves the quadriceps muscle and tendon, but requires careful assessment of patellar mobility as well as size and bulk of the quadriceps muscle mass.

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Figure 2

Mini-medial Parapatellar Approach, Option 1Initial Skin IncisionMake the skin incision centered over the medial one-third of the patella extending from 1 cm above the superior pole of the patella to the tibial tubercle. The length of this incision will vary depending on the anatomy, but generally range between 4–6". It is recommended to perform the skin incision in a flexed position which will help minimize the sensitivity with kneeling. It is extremely important to monitor the proximal and distal margins of the incision in order to make certain there is not increased tension from excessive retraction. Extension of the skin incision may be necessary during the procedure depending on the anatomy and the quality of the soft tissue. Keep in mind that the priority is to minimize the soft tissue trauma and to preserve the quadriceps muscle.

ApproachMake a mini-medial parapatellar arthrotomy, beginning at the top medial corner of the patella and continuing down along the patellar tendon, ending at the patellar tendon insertion (Figure 2).

Once the incision has been made, ensure the release of any soft tissue adhesions.

Deep ExposureWith the knee in the extended position, perform the arthrotomy from 1–2 cm above the superior pole of the patella, extending to the level of the tibial tubercle. Perform fat pad excision to facilitate exposure and to improve patellar mobility. Perform a medial release at this time to only release what is necessary for the existing deformity. This will also allow for easy placement of the medial retractors for protection of the medial collateral ligament as well as exposure of the proximal tibia later in the procedure.

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Figure 3

Note: Because the patella is not everted in this technique, the patellar tendon may be tight and thus require greater retractor tension. Take special care not to violate the patellar tendon insertion point. A small-headed pin, suture or staple may be placed at the patellar tendon insertion to prevent avulsion.

Mid-vastus Approach, Option 2Initial Skin IncisionMake the skin incision centered over the medial one-third of the patella extending from 1 cm above the superior pole of the patella to the tibial tubercle (Figure 3). The length of this incision will vary depending on the anatomy, but generally range between 4–6". It is recommended to perform the skin incision in a flexed position which will help minimize the sensitivity with kneeling. It is extremely important to monitor the proximal and distal margins of the incision in order to make certain there is not increased tension from excessive retraction. Extension of the skin incision may be necessary during the procedure depending on the anatomy and the quality of the soft tissue. Keep in mind that the priority is to minimize the soft tissue trauma and to preserve the quadriceps muscle.

6

ApproachExtend the capsular incision in a straight line proximally obliquely cutting across VMO muscle fibers. This is most easily performed with the knee flexed near 90 degrees. The VMO incision typically extends for a distance of 1–3 cm. This length is partially dependent on the VMO insertion site onto the patella. If the VMO has a proximal patellar insertion, the VMO incision may be only 1–2 cm. If the VMO inserts into the patella as far distally as mid-patella, the incision into the VMO may reach 3–4 cm. If it is later determined that a more extensile incision is required for proper exposure, the VMO incision can be continued straight proximally.

Note: The strongest fascia for closure is on the deep surface of the VMO. When the capsule is closed, this deep fascial layer must be included in the sutures. Typically only two or three sutures are required to close the mid-vastus VMO extension of the capsular incision.




7


Sub-vastus Approach, Option 3Initial Skin IncisionMake the skin incision centered over the medial one-third of the patella extending from 1cm above the superior pole of the patella to the tibial tubercle. The length of this incision will vary depending on the anatomy, but generally range between 4–6". It is recommended to perform the skin incision in a flexed position which will help minimize the sensitivity with kneeling. It is extremely important to monitor the proximal and distal margins of the incision in order to make certain there is not increased tension from excessive retraction. Extension of the skin incision may be necessary during the procedure depending on the anatomy and the quality of the soft tissue. Keep in mind that the priority is to minimize the soft tissue trauma and to preserve the quadriceps muscle.

ApproachMake a horizontal arthrotomy along the inferior border of the VMO leaving a cuff of retinaculum for closure (Figure 4). Complete the arthrotomy in a standard manner along the medial patellar tendon.


Figure 4

8



9


Slide the Slidex® Distal Resection Block and cut block adaptor into the anterior holes of the valgus wing until the Slidex® Resection Block contacts the anterior cortex of the femur (Figure 7).

Figure 5 Figure 7Figure 6

Distal Femoral ResectionUtilize the .375" intramedullary (IM) drill to penetrate the intracondylar notch and dense cancellous bone of the distal femur to a depth of approximately 1.5–2" (3.5–5 cm). Place the canal entry location 1cm above the insertion of the posterior cruciate ligament and slightly medial in the intercondylar notch (Figure 5).

Choose the appropriate left or right valgus wing and slide it onto the IM rod. Introduce the IM rod to the femoral canal to depressurize the canal. Slide the valgus wing until it rests against the medial distal condyle (Figure 6). The “left” or “right” engraving on the block must face distally based on the operative leg.

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To confirm the valgus angle, the alignment handle can be inserted into the cut block adaptor and a ¼" alignment rod can be inserted and extended to the center of the femoral head (Figure 8).

Pin the Slidex® Distal Resection Block into place using 1/8" quick release drill pins in the most proximal pin holes of the block (Figure 9).

Remove the valgus wing by removing the IM rod and pulling the valgus wing and cut block adaptor distally away from the distal resection block, leaving the Slidex® Distal Resection Block in place.

Figure 9Figure 8

11


Two resection slots of 0 or +3 mm are available for the distal resection. The 0 mm slot will resect 9 mm from the most prominent part of the medial distal condyle. If additional distal resection is required, the +3 mm slot will resect 12 mm. If additional distal resection is required beyond the +3 mm slot, shift the resection guide proximal by utilizing the +2 or +4 mm 1⁄8" pin holes.

Use a .054" saw blade to complete the distal resection through the selected slot. Check the resected distal femur using a flat instrument. Recut or file as necessary to ensure proper resection. For additional stability, the femoral block handle can be utilized (Figure 10).

Figure 10

12

Femoral SizingWith the epicondylar and/or A/P femoral axis marked, place the adjustable A/P Sizer flat against the resected distal surface with the feet in contact with the posterior condyles of the femur.

Adjustable Rotation Feet, Option 1Adjustable dial feet can be used with the A/P Sizer. The adjustable rotation feet are right/left specific and may be externally rotated from 0–10 degrees. Adjust the dial to the desired rotation using a setting of 3 degrees as an initial setting (Figure 11).

The femoral component size can now be read from the central scale. If the size indicated is between component sizes, the +2 holes may be utilized in combination with downsizing to the next smaller component size. This is accomplished by shifting the femoral component position 2 mm anteriorly (+2 holes) increasing the posterior condylar resection by 2 mm and increasing the flexion gap.

To further evaluate the proper size of femoral component in the M/L dimension, insert the appropriately sized M/L width checker into the A/P Sizer (Figure 12).

After confirming the femoral component size, use 1/8" drill pins to create the hole locations for the 4-in-1 cutting block by utilizing the most posterior drill holes (Figure 13).

Note: The final M/L position of the component is not determined during this step, but is addressed later in the technique.

Figure 11 Figure 12 Figure 13

13


Fixed Rotation Feet, Option 2Place the A/P Sizer flat against the resected distal femoral surface with the posterior feet in contact with the posterior condyles of the femur (Figure 14).

The 0, 3 and 5 degree rotational feet are right/left specific and should correspond to the operative side.

If the size indicated is in between component sizes, the +2 holes may be utilized in combination with downsizing to the next smaller component size. This is accomplished by shifting the femoral component position 2 mm anterior (+2 holes) increasing the posterior condyle resection by 2 mm and increasing the flexion gap.

To further evaluate the proper size of femoral component in the M/L dimension, insert the appropriately sized M/L width checker into the A/P (Figure 15). After confirming the femoral component size, use 1/8" drill pins to create the hole locations for the 4-in-1 cutting block (Figure 16).

Note: The final M/L position of the component is not determined during this step but is addressed later in the technique.


14

Femoral 4-in-1 ResectionsChoose the slotted femoral Slidex® A/P 4-in-1 Block that matches the selected size on the A/P Sizer and place it into the 1/8" holes drilled into the distal femur (Figure 17). A .054" feeler blade can be used to determine the amount of anterior cortex resection.

The femoral block handle can be placed onto this cut block if additional support is desired (Figure 18). The handle can be used to assist in sliding the cut block medially and laterally.

Note: Take extra caution to avoid angling the Slidex® A/P 4-in-1 Cut Block when using handle.

Figure 17 Figure 18

15


Always utilize retractors to aid in stability and to protect soft tissues. Perform the anterior resection followed by the posterior resection. Then perform the posterior chamfer resection followed by the anterior chamfer resection (Figure 19).

Note: If implanting a CR Femoral Component, femoral trialing can be completed after femoral 4-in-1 resections are made.

PS Box PreparationUniversal Bone Conserving GuidePlace the Microplasty® Universal PS Box Guide on the prepared distal femur. Take care to offset the universal box resection guide 1–2 mm laterally to aid in patellar tracking (Figure 20).

Secure the box resection guide using 1⁄8" bone nails through any of the holes located on the guide.

Figure 19 Figure 20

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Figure 22

Position the PS Box Chisel, with the beveled edge facing distally into the resection slot. Impact the PS Box Chisel to a depth approximately one half the thickness of the femur (Figure 21).

Note: The Microplasty® Universal Box Guide is a bone conserving cut and is only compatible with a Vanguard® PS Open Box Femoral Component.

Using a .054" sawblade, resect along the interior of the box guide with an oscillating saw or reciprocating saw to the depth of the box chisel (Figure 22).

Cuts should be made moving from the anterior to posterior portion. Continue impacting the chisel until the intercondylar bone is removed.

Figure 21

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Figure 23 Figure 24

Captured Uncaptured

Remove Universal PS Box Guide. Place the PS Open Box Gauge into the resected intercondylar bone to determine if appropriate depth and width of bone has been removed (Figure 23).

Note: The Universal PS Box Guide only prepares the femur for a Vanguard® PS Open Box Femoral Component. The Universal PS Box Guide is available in captured or uncap-tured configurations (Figure 24). An ucaptured Universal PS Box Guide is available for use with a sagittal saw.

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Figure 25 Figure 26

Tibial Resection Extramedullary Slidex® Tibial Resection GuideWith the knee flexed, place the spring loaded arms of the ankle clamp around the distal tibia just above the malleoli (Figure 25).

Adjust the height of the tibial resection block by turning the red locking knob on the Extramedullary (EM) Tibial Guide (Figure 26).

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Figure 27

With the tibial resection guide in an upward position, place the Slidex® Tibial Resection Block against the proximal tibia (Figure 27).

From the sagittal view, turn the red knob on the bottom of the EM Guide and adjust the EM Guide along the perpendicular shaft of the guide bottom until the tubular body is parrallel (for 0 degree posterior slope) with the shaft of the tibia (Figure 28).

Figure 28

Once correct alignment of the EM Guide is achieved from the sagittal view, rotate the resector until the shaft of the resector is just medial to the tibial tubercle in the coronal view. Adjust the varus/valgus slope of the resection head by changing the M/L position of the resector ankle clamp assembly (Figure 28).

Varus/Valgus Adjustment

Slope Adjustment

20

Insert the Slidex® Tibial Stylus into the desired holes for appropriate tibial resection. When referencing the deepest portion of the unaffected condyle, set the stylus to read 8–10mm. Set the stylus to read 2–4 mm when referencing the most affected condyle (Figure 29).

Once the correct position is established, 1⁄8" drill pins are used to secure the cutting block to the tibia through the most distal holes.

Insert the 0mm Slidex® Capture into the Slidex® Tibial Resection Block by positioning the dovetail lock on the bottom of the plate with the lateral portion of the top of the block body. Insert the dovetail into the groove and slide the plate medially, which will lock the plate to the resection body preventing unintended slope or tilt. The tibial plateau is resected using .054" saw blade (Figure 30). If additional tibial plateau needs to be resected, the +1 mm Slidex® Capture can be inserted into the Slidex® Tibial Resection Block. The resection guide without the modular capture attached represents a +2 mm surface resection.

Note: In addition to using the Slidex® Tibial Cutting Block, left and right fixed tibial cutting guides can be utilized as well (Figure 31).


21


Tibial SizingPlace the knee in maximum flexion and sublux the tibia anteriorly using a PCL retractor and placing a Z-retractor medially and laterally. Using the tibial template, select the tibial tray size that provides the appropriate coverage in both the A/P and the M/L planes (Figure 32).

Base the rotation on the position of the template relative to the tibial tubercle and the malleolar axis. Make an extramedullary alignment check by placing the 1⁄4" alignment rod through the tibial baseplate handle (Figure 33). Slight external rotation is preferable to optimize patellofemoral tracking.

When correct rotation has been determined, mark the position by extending the anterior marks of the template onto the anterior tibia with electrocautery (Figure 34).

Note: Take extra caution to avoid internal rotation of the tibial tray due to the presence of lateral soft tissue.


22

Tibial Stem PreparationI-beam Stem PunchAssemble the I-beam Punch Guide Mask onto the tibial template and pin in place using 1⁄8" medium bone nails. Use the three-sided box chisel prior to the I-beam punch (Figure 35).

Impact the three-sided chisel with the A/P etching facing anterior and remove. Rotate the chisel 180 degrees and impact a second time to complete the cut for the I-beam Punch.

Carefully impact the I-beam Stem Punch through the punch guide until it reaches the stop to achieve the appropriate depth (Figure 36).

While the stem is being prepared, the trial can be built. Once stem preparation is complete, remove the tibial template and I-beam Punch Mask and insert assembled tibial trial into the tibia (Figure 37).

Note: If the cruciate stem is selected, follow the technique above, substituting the I-beam Mask, three-sided box chisel, I-beam Punch and Stem with the Cruciate Mask, Cruciate Punch and trial cruciate stem.


23


Patellar Resection, Tilt the patella to 90 degrees and remove the osteophytes and peripatellar tissues down to the level of the tendinous insertions of the quadriceps and patellar tendons. Determine the level of the cut through caliper measurement of the total patellar thickness (Figure 38).

Surface Clamp A magnetic depth stylus may be utilized to determine the appropriate resection level (Figure 39). Perform the initial patellar resection utilizing the patella clamp surface cut guide. Clamp the guide to perform a flat cut across the patella.

Care should be taken to restore original patella thickness to prevent overstuffing of the patellofemoral joint. If a single peg patellar component is utilized, use the single peg patellar drill guide to locate the placement of the central peg. Drill the central hole using the 5/16" Series A patellar drill. Select a trial patellar component to optimize coverage without increasing patellar thickness beyond pre-resection height.

If a 3-peg patellar component is to be implanted, place the appropriately sized 3-peg drill guide onto the resected patella and use the 1/4" patellar drill to prepare for the component pegs (Figure 40).

Figure 39Figure 38 Figure 40

Vanguard® Patella Offerings

Diameter (mm)

25 28 31 34 37 40

1-pegStd. 8.0 8.0 8.0 8.5 10.0 10.0

Thin 6.2 6.2 6.2 7.8 8.6 N/A

3-pegStd. 8.0 8.0 8.0 8.5 10.0 10.0

Thin 6.2 6.2 6.2 7.8 8.6 N/A

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Patella MillingInset Single Peg Patella using the Vanguard® Patella MillTilt the patella to 90 degrees and remove the osteophytes and peripatellar tissues down to the level of the tendinous insertions of the quadriceps and patellar tendon. Determine the patella thickness by using calipers.

Size the patella using the mill bushings (Figure 41). Attach the size-specific bushing to the mill handle after the appropriate size patella has been determined. Based on patella size and thickness, determine if a standard or thin patella should be used. Firmly clamp the patella with the mill handle paying careful attention not to tilt the patella.

Attach the appropriate size-specific patella reamer to the reamer shaft (Figure 42). Attach the proximal shaft to a power drill. Insert the reamer basket into the mill bushing and allow the reamer’s central bit to rest on the apex of the patella bone.

Figure 41 Figure 42

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Attach the appropriate thickness magnetic spacer (marked “Bit”) to the adjustable depth stop. Set the adjustable stop by depressing the button on its side and slide the stop down until the bottom of the spacer touches the mill bushing (Figure 43).

Note: The magnetic spacer bit includes the depth of the peg. Do not sink the drill bit prior to setting the adjustable stop.

Remove the magnetic spacer and ream until the adjustable stop touches the mill bushing. Remove the reamer assembly and then disengage the mill handle by pulling the thumb trigger towards the handle.

Note: If a 3-peg patellar component is to be implanted, the appropriate sized surface reamer will be used to prepare the inset surface. The magnetic spacer marked with a red dot should be used to correctly establish the resection depth. The 3-peg drill guide is tapped into the prepared patella inset and the 1⁄4" patellar drill is used to make the holes for the component pegs.

Figure 43

26

Trial ReductionWith all bony surfaces prepared and soft tissue debrided, complete a trial reduction with the trial components. Place and impact the trial femoral component on the femur with the femoral inserter (Figure 44).

Select trial bearing inserts to determine the appropriate thickness of the tibial component.

Select a single peg or three peg trial patellar component that corresponds to the diameter and thickness and place it onto the patella. When the trial components are in place, check range-of-motion and stability of the knee. If tightness is found M/L, in flexion or in extension, appropriate soft tissue releases must be performed.

Note: If trialing a PS knee, insert the appropriate PS trial post to the insert bearing (Figure 45). If additional constraint is needed, utilize the PS Plus trial post.

Note: If distal femoral pegs are selected to be added to the femoral component, drill for pegs through the designated holes provided in the femoral trial (Figure 45).

Figure 44 Figure 45

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Tibial Implant Insertion Assemble the modular tibial component, by choosing the appropriate stem (most primary cases will require a 40 mm stem). The locking screw for the stem is included in the stem’s packaging. Place the stem taper on the bottom of the appropriate modular tibial baseplate. Be sure that the alignment keys match between stem and plate. Impact the tip of the stem once with a mallet to seat the stem taper.

Note: The stem taper will hold the stem and plate together. The screw is tightened into the threads of the stem for added stem fixation. Plugs can be left in the screw holes of the baseplate if screw fixation is not used. Utilize the tibial impactor to firmly seat the component (Figure 46). Remove excess cement in a routine manner.

Optional screw fixation: Using the drill guide and 1/8" drill, prepare a hole for screw acceptance.

Note: The low-profile screws may be angled at 15 degrees in any direction to engage the best available cancellous and/or cortical bone. Frequent reference to the X-rays will guide the drilling and screw insertion sequence.

With the baseplate firmly fixed, the provisional bearing may be reinserted, and a trial reduction performed to confirm joint tension and stability.

Figure 46

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Femoral Implant InsertionNote: If distal femoral pegs were selected to be added to the femoral component, use the peg wrench (Part No. 32-486122) to assemble the pegs to the femoral component. The peg wrench may also be used to remove pegs from the femoral component.

Place the appropriate femoral component on the end of the femur and insert it manually as far as possible (until about 1 cm of space remains between the component and the distal femur). Fully seat the component using the control femoral impactor (Figure 47).

Remove the extruded cement in a routine manner. Running through a range-of-motion will help to pressurize the cement.

Patellar Implant InsertionPlace the appropriate patellar component into the patella and push it into position with finger pressure so the peg(s) engage(s) the prepared hole(s).

Position the patellar clamp onto the component and tighten the handle until the clamp head contacts the component. Clamp tightly to compress the implant (Figure 48). Remove extruded cement in a routine manner. The clamp should be left in position until the cement cures.

Figure 47 Figure 48

29


Locking Bar Insertion Place the appropriate polyethylene bearing insert on the tibial baseplate and push posteriorly as far as possible using finger pressure. The polyethylene bearing must be flat on the baseplate in all directions. The locking bar, packaged with the tibial baseplate, is inserted into the medial side of the anterior tibial baseplate/polyethylene interface as far as possible using finger pressure (Figure 49). The locking bar must be tight upon insertion and should be too tight to insert completely with finger pressure only.

Place the large curved end of the locking bar insertion forceps in the notch on the locking bar. The smaller square end should be placed in the notch of the anterior post of the tibial baseplate. Make sure the smaller square end catches on the post of the tibial tray and does not block the path of the locking bar. Squeezing the forceps will gradually push the locking bar until it clicks into place (Figure 50). A visual and audible confirmation should be made to ensure complete locking bar insertion.

Figure 49 Figure 50

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Product Label Part Number Description Size

A

32-485004 32-485005 32-485006 32-485007

Microplasty® 4 Degree Valgus WingMicroplasty® 5 Degree Valgus WingMicroplasty® 6 Degree Valgus WingMicroplasty® 7 Degree Valgus Wing

—

B

32-48501432-485015 32-485016 32-485017

Microplasty® 4 Degree Block AttachMicroplasty® 5 Degree Block AttachMicroplasty® 6 Degree Block AttachMicroplasty® 7 Degree Block Attach

—

C 32-485001 Microplasty® Fixed Distal Cut Block —

D 32-485000 Microplasty® Slidex® Distal Cut Block —

E32-485052 32-485051

Vanguard® Microplasty® 10 Degree Dial Left FeetVanguard® Microplasty® 10 Degree Dial Right Feet

——

F32-48505532-48505332-485054

Vanguard® Microplasty® Neutral Posterior FeetVanguard® Microplasty® 3 Degree Left Posterior Feet

Vanguard® Microplasty® 3 Degree Right Posterior Feet

———

AD

E

B

F

C

G

H

595302 Vanguard® Microplasty® Femoral Preparation Instrumentation

I

K

J

L

31



G 32-485025 Vanguard® IM Canal Drill with Step —

H 32-485030 Vanguard® T-style IM Rod —

I 32-485020 Microplasty® Femoral Block Handle —

J 32-485050 Vanguard® Microplasty® Slidex® A/P Sizer —

K

32-485102 32-485103 32-485104 32-485105 32-485106 32-485107

Microplasty® Slidex® Femoral BlockMicroplasty® Slidex® Femoral BlockMicroplasty® Slidex® Femoral BlockMicroplasty® Slidex® Femoral BlockMicroplasty® Slidex® Femoral BlockMicroplasty® Slidex® Femoral Block

60 mm62.5 mm65 mm

67.5 mm70 mm75 mm

L 32-487070 Vanguard® A/P Shift Block —

Additional Microplasty® Femoral Instrumentation (Not Shown)

32-485034 32-485037

Microplasty® 4 Degree Block Attachment (Pocket)Microplasty® 7 Degree Block Attachment (Pocket)

—

32-485049 Vanguard® A/P Sizer Long Probe Stylus —

32-485056 32-485057

Vanguard® Microplasty® 5 Degree Left Posterior FeetVanguard® Microplasty® 5 Degree Right Posterior Feet

—

32-48510032-48510132-48510932-485108

Vanguard® Microplasty® Slidex® Femoral BlockVanguard® Microplasty® Slidex® Femoral BlockVanguard® Microplasty® Slidex® Femoral BlockVanguard Microplasty® Slidex® Femoral Block

55 mm57.5 mm72.5 mm80 mm

G

H

595302 Vanguard® Microplasty® Femoral Preparation Instrumentation (Continued)

I

K

J

L

32


G 32-485025 Vanguard® IM Canal Drill with Step —

H 32-485030 Vanguard® T-style IM Rod —

I 32-485020 Microplasty® Femoral Block Handle —

J 32-485050 Vanguard® Microplasty® Slidex® A/P Sizer —

K

32-485102 32-485103 32-485104 32-485105 32-485106 32-485107

Microplasty® Slidex® Femoral BlockMicroplasty® Slidex® Femoral BlockMicroplasty® Slidex® Femoral BlockMicroplasty® Slidex® Femoral BlockMicroplasty® Slidex® Femoral BlockMicroplasty® Slidex® Femoral Block

60 mm62.5 mm65 mm

67.5 mm70 mm75 mm

L 32-487070 Vanguard® A/P Shift Block —

Additional Microplasty® Femoral Instrumentation (Not Shown)

32-485034 32-485037

Microplasty® 4 Degree Block Attachment (Pocket)Microplasty® 7 Degree Block Attachment (Pocket)

—

32-485049 Vanguard® A/P Sizer Long Probe Stylus —

32-485056 32-485057

Vanguard® Microplasty® 5 Degree Left Posterior FeetVanguard® Microplasty® 5 Degree Right Posterior Feet

—

32-48510032-48510132-48510932-485108

Vanguard® Microplasty® Slidex® Femoral BlockVanguard® Microplasty® Slidex® Femoral BlockVanguard® Microplasty® Slidex® Femoral BlockVanguard Microplasty® Slidex® Femoral Block

55 mm57.5 mm72.5 mm80 mm


A 32-485510 Microplasty® I-beam Punch Mask —

B 32-485511 Microplasty® Cruciate Punch Mask —

C

32-485500 32-485501 32-485502 32-485503 32-485504 32-485505 32-485506 32-48550732-485508

Microplasty® Tibial TemplateMicroplasty® Tibial TemplateMicroplasty® Tibial TemplateMicroplasty® Tibial TemplateMicroplasty® Tibial TemplateMicroplasty® Tibial TemplateMicroplasty® Tibial TemplateMicroplasty® Tibial TemplateMicroplasty® Tibial Template

59 mm 63 mm67 mm71 mm75 mm79 mm83 mm87 mm91 mm

A B

C

595303 Vanguard® Microplasty® Tibial Preparation Instrumentation—Top Tray595302 Vanguard® Microplasty® Femoral Preparation Instrumentation (Continued)

33



A 32-485550 Microplasty® EM Tibial Guide —

B

32-341260 32-34126132-341262 32-341263 32-34126432-341265 32-341266 32-341267 32-341268

Biomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate Trial

59 mm63 mm67 mm71 mm75 mm79 mm83 mm87 mm91 mm

C 32-485560 Vanguard® Tibial Stylus —

D 32-485521 Microplasty® Cruciate Punch —

E 32-485520 Vanguard® Microplasty® I-beam Punch —

F 32-485555 Vanguard® Microplasty® Slidex® Tibial Stylus —

G 32-485525 Vanguard® I-beam Box Chisel —

595303 Vanguard® Microplasty® Tibial Preparation Instrumentation—Bottom Tray

A

D

E

B

FG

KJ L

C

H I M

34


A 32-485550 Microplasty® EM Tibial Guide —

B

32-341260 32-34126132-341262 32-341263 32-34126432-341265 32-341266 32-341267 32-341268

Biomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate TrialBiomet® Tibial Plate Trial

59 mm63 mm67 mm71 mm75 mm79 mm83 mm87 mm91 mm

C 32-485560 Vanguard® Tibial Stylus —

D 32-485521 Microplasty® Cruciate Punch —

E 32-485520 Vanguard® Microplasty® I-beam Punch —

F 32-485555 Vanguard® Microplasty® Slidex® Tibial Stylus —

G 32-485525 Vanguard® I-beam Box Chisel —

595303 Vanguard® Microplasty® Tibial Preparation Instrumentation—Bottom Tray


H 32-341310 Biomet® I-beam Trial Stem 40 mm

I 32-341314 Biomet® Finned Trial Stem 40 mm

J32-485556 32-485557

Vanguard® Microplasty® Tibial Resection Head LeftVanguard® Microplasty® Tibial Resection Head Right

—

K32-485558 32-485559

Vanguard® Microplasty® Slidex® Tibial Zero PlateVanguard® Microplasty® Slidex® Tibial +1 Plate

—

L RD140512 Microplasty® Right Tibial Cut Block —

M RD140513 Microplasty® Left Tibial Cut Block —

35


595301 Vanguard® Universal Instrumentation—Top Tray

NM

L


A 32-420160 Vanguard® Pin Inserter/Extractor —

B 32-486257 Vanguard® Drill with Stop 1⁄8"

C 32-486265 Vanguard® Sterile Quick Release Drill Pin (PK/2) 1⁄8"

D 32-486255 Vanguard® Quick Release Trocular Pin (PK/2) —

E 32-486000 Vanguard® Feeler Blade —

F 32-486100 Vanguard® Lug Drill with Stop 1⁄4"

G 32-486260 Vanguard® Bone Nail Holder —

H32-48625032-48625232-486253

Vanguard® Bone Nail (PK/2)Vanguard® Bone Nail (PK/2)Vanguard® Bone Nail (PK/2)

SmallMediumLarge

I 32-486259 Vanguard® Quick-Release Drill Chuck —

J 32-467618 Vanguard® Long Pin Inserter —

K 32-486130 Tibial Trial Handle/Alignment Tower —

L 32-486125 Vanguard® Locking Bar Inserter —

need labels

J

E F

BA

LK

H

HC

D

G

H

I

36

595301 Vanguard® Universal Instrumentation—Bottom Tray

H

A

B

F

C

G

D

E


A 32-486135 Alignment Rod (PK/2) —

B 32-486201 Vanguard® Femoral/Tibial Impactor —

C 32-486150 Posterior Ostephyte Chisel —

D 32-486210 Vanguard® Slaphammer —

E 32-486205 Vanguard® Alignment CR Inserter —

F 32-486202 Vanguard® Tibial Poly Impactor —

G 32-486209 Vanguard® PS Box Impactor —

H 32-486120 Vanguard® Hex Screwdriver 3.5 mm

37


595308 Vanguard® PS Box Resection—Chisel


A

32-48720232-48720332-48720432-48720532-48720632-487207

Vanguard® PS Box GuideVanguard® PS Box GuideVanguard® PS Box GuideVanguard® PS Box GuideVanguard® PS Box GuideVanguard® PS Box Guide

60 mm62.5 mm65 mm

67.5 mm70 mm75 mm

B 32-487217 Vanguard® PS Box Chisel —

C 32-487214 Vanguard® PS Box Gauge Angled —

D 32-487215 Vanguard® Open Box Resection Gauge —

E 32-487216 Vanguard® Closed Box Resection Gauge —

Additional PS Box Resection Instrumentation (Not Shown)

32-48720032-48720132-48720932-487208

Vanguard® PS Box GuideVanguard® PS Box GuideVanguard® PS Box GuideVanguard® PS Box Guide

55 mm57.5 mm72.5 mm80 mm

32-484030 32-484031

MP Elite BC Universal Box GuideMP Elite BC Universal Box Guide with Capture

—

A

CB E

A

D

38


A

32-48472032-48472232-48472432-48472632-484728

Series A Patella Trial Thin, 1 PegSeries A Patella Trial Thin, 1 PegSeries A Patella Trial Thin, 1 PegSeries A Patella Trial Thin, 1 PegSeries A Patella Trial Thin, 1 Peg

25 mm28 mm31 mm34 mm37 mm

B

32-48470032-48470232-48470432-48470632-48470832-484710

Series A Patella Trial STD, 1 PegSeries A Patella Trial STD, 1 PegSeries A Patella Trial STD, 1 PegSeries A Patella Trial STD, 1 PegSeries A Patella Trial STD, 1 PegSeries A Patella Trial STD, 1 Peg

25 mm28 mm31 mm34 mm37 mm40 mm

C 32-486502 Patella Caliper Scissor Style —

D

32-48476032-48476232-48476432-48476632-48476832-484770

Series A Patella Trial STD, 3 PegSeries A Patella Trial STD, 3 PegSeries A Patella Trial STD, 3 Peg Series A Patella Trial STD, 3 PegSeries A Patella Trial STD, 3 PegSeries A Patella Trial STD, 3 Peg


E

32-48478032-48478232-48478432-48478632-484788

Series A Patella Trial Thin, 3 PegSeries A Patella Trial Thin, 3 PegSeries A Patella Trial Thin, 3 PegSeries A Patella Trial Thin, 3 PegSeries A Patella Trial Thin, 3 Peg


K

595319 Biomet® Series A Patella Preparation Instrumentation—Top Tray

CDA B

KH I

E

F G

J

39



F

32-48653032-48653132-48653232-48653332-48653432-486535

Vanguard® Patella Mod 3 Peg Drill GuideVanguard® Patella Mod 3 Peg Drill GuideVanguard® Patella Mod 3 Peg Drill GuideVanguard® Patella Mod 3 Peg Drill GuideVanguard® Patella Mod 3 Peg Drill GuideVanguard® Patella Mod 3 Peg Drill Guide


G 32-486500 Patella Saw Guide —

H 32-486515 Vanguard® Patella Modular Cement Clamp Head —

I 32-486510 Vanguard® Patella Drill Guide/Cement Clamp Handle —

J 32-486501 Patella Saw Guide Stylus —

K 32-468470 Patella Drill with Stop 3 Peg —

Additional Instrumentation (Not Shown)32-48652032-48652132-48652232-48652332-48652432-486525

Series A Patella Modular 1 Peg Drill GuideSeries A Patella Modular 1 Peg Drill GuideSeries A Patella Modular 1 Peg Drill GuideSeries A Patella Modular 1 Peg Drill GuideSeries A Patella Modular 1 Peg Drill GuideSeries A Patella Modular 1 Peg Drill Guide


KH I

F G

J

595319 Biomet® Series A Patella Preparation Instrumentation—Top Tray (Continued)

40


F

32-48653032-48653132-48653232-48653332-48653432-486535

Vanguard® Patella Mod 3 Peg Drill GuideVanguard® Patella Mod 3 Peg Drill GuideVanguard® Patella Mod 3 Peg Drill GuideVanguard® Patella Mod 3 Peg Drill GuideVanguard® Patella Mod 3 Peg Drill GuideVanguard® Patella Mod 3 Peg Drill Guide


G 32-486500 Patella Saw Guide —

H 32-486515 Vanguard® Patella Modular Cement Clamp Head —

I 32-486510 Vanguard® Patella Drill Guide/Cement Clamp Handle —

J 32-486501 Patella Saw Guide Stylus —

K 32-468470 Patella Drill with Stop 3 Peg —

Additional Instrumentation (Not Shown)32-48652032-48652132-48652232-48652332-48652432-486525

Series A Patella Modular 1 Peg Drill GuideSeries A Patella Modular 1 Peg Drill GuideSeries A Patella Modular 1 Peg Drill GuideSeries A Patella Modular 1 Peg Drill GuideSeries A Patella Modular 1 Peg Drill GuideSeries A Patella Modular 1 Peg Drill Guide


595319 Biomet® Series A Patella Preparation Instrumentation—Bottom Tray


A 32-486800 Vanguard® Patella Clamp Handle —

B

32-48683032-48683132-48683232-48683332-486834

Vanguard® Patella BushingVanguard® Patella BushingVanguard® Patella BushingVanguard® Patella BushingVanguard® Patella Bushing


C 32-486805 Vanguard® Cement Clamp Bushing —

D 32-486802 Vanguard® Patella Reamer Shaft with Stop —

E

32-48681032-48681132-48681232-48681332-48681432-486815

Vanguard® Patella ReamerVanguard® Patella ReamerVanguard® Patella ReamerVanguard® Patella ReamerVanguard® Patella ReamerVanguard® Patella Reamer


F

32-48688032-48688232-48688432-48688632-486888

Vanguard® Patella Spacer Drill TipVanguard® Patella Spacer Drill TipVanguard® Patella Spacer Drill TipVanguard® Patella Spacer Drill TipVanguard® Patella Spacer Drill Tip

6.2 mm7.8 mm8.0 mm8.5 mm10 mm

B

E

F

DC

A

41


595304 Vanguard® PS Femoral Trials


A

32-48312432-48312632-48312832-48313032-48313232-483134

Vanguard® PS Femoral Trial LeftVanguard® PS Femoral Trial LeftVanguard® PS Femoral Trial LeftVanguard® PS Femoral Trial LeftVanguard® PS Femoral Trial LeftVanguard® PS Femoral Trial Left

60 mm62.5 mm65 mm

67.5 mm70 mm75 mm

B

32-48310432-48310632-48310832-48311032-48311232-483114

Vanguard® PS Femoral Trial RightVanguard® PS Femoral Trial RightVanguard® PS Femoral Trial RightVanguard® PS Femoral Trial RightVanguard® PS Femoral Trial RightVanguard® PS Femoral Trial Right

60 mm62.5 mm65 mm

67.5 mm70 mm75 mm

Additional PS Instrumentation (Not Shown)

32-48312032-48312232-48313332-483136

Vanguard® PS Femoral Trial LeftVanguard® PS Femoral Trial LeftVanguard® PS Femoral Trial LeftVanguard® PS Femoral Trial Left

55 mm57.5 mm72.5 mm80 mm

32-48310032-48310232-48311332-483116

Vanguard® PS Femoral Trial RightVanguard® PS Femoral Trial RightVanguard® PS Femoral Trial RightVanguard® PS Femoral Trial Right

55 mm57.5 mm72.5 mm80 mm

A

B

42

595305 Vanguard® CR Femoral Trials


A

32-48302432-48302632-48302832-48303032-48303232-483034

Vanguard® CR Femoral Trial LeftVanguard® CR Femoral Trial LeftVanguard® CR Femoral Trial LeftVanguard® CR Femoral Trial LeftVanguard® CR Femoral Trial LeftVanguard® CR Femoral Trial Left

60 mm62.5 mm65 mm

67.5 mm70 mm75 mm

B

32-48300432-48300632-48300832-48301032-48301232-483014

Vanguard® CR Femoral Trial RightVanguard® CR Femoral Trial RightVanguard® CR Femoral Trial RightVanguard® CR Femoral Trial RightVanguard® CR Femoral Trial RightVanguard® CR Femoral Trial Right

60 mm62.5 mm65 mm

67.5 mm70 mm75 mm

Additional CR Instrumentation (Not Shown)

32-48302032-48302232-48303332-483036

Vanguard® CR Femoral Trial LeftVanguard® CR Femoral Trial LeftVanguard® CR Femoral Trial LeftVanguard® CR Femoral Trial Left

55 mm57.5 mm72.5 mm80 mm

32-48300032-48300232-48301332-483016

Vanguard® CR Femoral Trial RightVanguard® CR Femoral Trial RightVanguard® CR Femoral Trial RightVanguard® CR Femoral Trial Right

55 mm57.5 mm72.5 mm80 mm

32-486123 Vanguard® Femoral Trial Pegs —

32-486122 Vanguard® Femoral Peg Wrench —

A

B

43


595337 Vanguard® CR Standard Bearing Trials


A

32-48370032-48370232-48370432-48370632-483708

Vanguard® Standard CR Bearing TrialVanguard® Standard CR Bearing TrialVanguard® Standard CR Bearing TrialVanguard® Standard CR Bearing TrialVanguard® Standard CR Bearing Trial

10x59 mm12x59 mm14x59 mm16x59 mm18x59 mm

B

32-48372032-48372232-48372432-48372632-483728


10x63/67 mm12x63/67 mm14x63/67 mm16x63/67 mm18x36/67 mm

C

32-48374032-48374232-48374432-48374632-483748



D

32-48376032-48376232-48376432-48376632-483768



E

32-48378032-48378232-48378432-48378632-483788



F 32-347100 Maxim® Trial Poly Puller —

G 32-487999 Trial Poly Puller - Straight —

BA C D E

F

G

44

595320 Vanguard® Anterior Stabilized Bearing Trials—Top Tray


A

32-48902032-48902232-48902432-48902632-48902832-489030

Vanguard® Anterior Stabilized Bearing TrialVanguard® Anterior Stabilized Bearing TrialVanguard® Anterior Stabilized Bearing TrialVanguard® Anterior Stabilized Bearing TrialVanguard® Anterior Stabilized Bearing TrialVanguard® Anterior Stabilized Bearing Trial

10x63 mm12x63 mm14x63 mm16x63 mm18x63 mm20x63 mm

B 32-483896 Vanguard® Universal Tibial Trial Removal Tool —

C

32-48904032-48904232-48904432-48904632-48904832-489050



BA C

45


595320 Vanguard® Anterior Stabilized Bearing Trials—Bottom Tray

BA C D


A

32-48906032-48906232-48906432-48906632-48906832-489070



B

32-48908032-48908232-48908432-48908632-48908832-489090



C

32-48910032-48910232-48910432-48910632-48910832-489110



D

32-48912032-48912232-48912432-48912632-48912832-489130



46

595338 Vanguard® 5-in-1 Universal Bearing Trials—Top Tray

A

F H

A

B

B

C

G

C

D

D

E

E


A32-48380032-483802

Vanguard® Universal 5-in-1 Bearing TrialVanguard® Universal 5-in-1 Bearing Trial

10x59 mm12x59 mm

B32-48382032-483822


10x63/67 mm12x63/67 mm

C32-48384032-483842


10x71/75 mm12x71/75 mm

D32-48386032-483862


10x79/83 mm12x79/83 mm

E32-48388032-483882


10x87/91 mm12x87/91 mm

F

32-48390032-48390132-48391032-483911

Vanguard® PS Modular Trial PostVanguard® PS Plus Modular Trial Post

Vanguard® PS Trial Post LockingVanguard® PS Plus Trial Post Locking

————

G 32-483896 Vanguard® Universal Tibial Trial Removal Tool —

H

32-48390632-48390732-48390832-483909

Vanguard® SSK PS Trial Post LockingVanguard® SSK PS Trial Post Locking

Vanguard® SSK PSC Trial Post LockingVanguard® SSK PSC Trial Post Locking

SmallLargeSmallLarge

47


595338 Vanguard® 5-in-1 Universal Bearing Trials—Bottom Tray

Product Label Size Description Size

A

32-48380432-48380632-48380832-48381032-48381232-483814

Vanguard® Universal 5-in-1 Bearing TrialVanguard® Universal 5-in-1 Bearing TrialVanguard® Universal 5-in-1 Bearing TrialVanguard® Universal 5-in-1 Bearing TrialVanguard® Universal 5-in-1 Bearing TrialVanguard® Universal 5-in-1 Bearing Trial


B

32-48382432-48382632-48382832-48383032-48383232-483834


14x63/67 mm16x63/67 mm18x63/67 mm20x63/67 mm22x63/67 mm24x63/67 mm

C

32-48384432-48384632-48384832-48385032-48385232-483854


14x71/75 mm16x71/75 mm18x71/75 mm20x71/75 mm22x71/75 mm24x71/7 5 mm

D

32-48386432-48386632-48386832-48387032-48387232-483874



E

32-48388432-48388632-48388832-48389032-48389232-483894



BA C D E

48

Continued on next page.

Biomet Orthopedics 01-50-150056 East Bell Drive Date: 12/09 P.O. Box 587Warsaw, Indiana 46581 USA

RECOMMENDATIONS FOR THE CARE AND HANDLINGBIOMET® SURGICAL INSTRUMENTS AND INSTRUMENT CASES

DESCRIPTIONBiomet® instruments and instrument cases are generally composed of aluminum, stainless steel, and/or polymeric materials. The cases may be multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may consist of trays, holders, and silicone mats. The instrument cases are perforated to allow steam to penetrate these various materials and components. The instrument cases will allow sterilization of the contents to occur in a steam autoclave utilizing a sterilization and drying cycle that has been validated by the user for the equipment and procedures employed at the user facility. Instrument cases do not provide a sterile barrier and must be used in conjunction with a sterilization wrap to maintain sterility.

MATERIALSAluminumStainless SteelPolymeric Materials

DISCLAIMERBiomet® instrument cases are intended to protect instrumentation and facilitate the sterilization process by allowing steam penetration and drying. Biomet has verified through laboratory testing that its instrument cases are suitable for the specific sterilization methods and cycles for which they have been tested. Health care personnel bear the ultimate responsibility for ensuring that any packaging method or material, including a reusable rigid container system, is suitable for use in sterilization processing and sterility maintenance in a particular health care facility. Testing should be conducted in the health care facility to ensure that conditions essential to sterilization can be achieved. Biomet does not accept responsibility or liability arising from a lack of cleanliness or sterility of any medical devices supplied by Biomet that should have been properly cleaned and/or sterilized by the end user prior to use.

CLEANING AND DECONTAMINATION 1. Removal of Gross Contamination-The effectiveness of subsequent decontamination pro-

cesses depends on prior removal of gross soil as it may be impaired by dried or coagulated protein. Gross soil should be removed under running water using a mechanical aid such as a brush with rigid nylon bristles. Care should be taken to avoid splashing and generating aerosols by holding instruments below the surface of the water in a sink into which water is running and continuously draining. Instruments should not be held under a running tap, as this is likely to result in splashing. Operatives should wear protective equipment including gloves and goggles. Care should be taken to avoid penetrating or cutting injuries. Particular attention should be taken to remove all debris from all cannulations and obscure holes in the instruments.

2. Disassembly-The majority of surgical instruments and trial prostheses are constructed in such a way that they will not require disassembly. However, some of the more complex instruments are made of several components and these should be disassembled into their individual parts prior to decontamination. In most cases the method of disassembly is self-evident. Loosen and/or disassemble instruments with removable parts. Screws or bolts on some instruments can be loosened for cleaning but are self-retaining to prevent loss.

3. Washing/Disinfecting- It is recommended that the instruments, disassembled as required, be decontaminated using an automatic washer-disinfection unit utilizing thermal disinfection. This should preferably be of the ultrasonic or continuous tunnel process type. The cabinet type is an acceptable alternative if a continuous process machine is not available. (Typical initial cleaning temperature is at or below 95° F (35°C), followed by a hot water disinfectant rinse where the surface temperature of the instruments should reach a minimum temperature of 160°F (71°C) for a minimum of 3 minutes, 176°F (80°C) for a minimum of 1 minute, or 194°F (90°C) for 1 second.) Compatible detergents and rinse aids may be used as recom-mended by the manufacturer of the washer-disinfection unit. These detergents and/or rinse aids, however, should be of neutral or near neutral pH. Excessively acidic or alkaline solutions may corrode aluminum instruments or instrument cases.

PREPARATION AND ASSEMBLYAfter cleaning/disinfecting, the disassembled instruments should be reassembled and placed in their proper locations in the instrument cases.

CARE AND HANDLING OF INSTRUMENTS 1. General. Surgical instruments and instrument cases are susceptible to damage for a variety

of reasons including prolonged use, misuse, rough or improper handling. Care must be taken to avoid compromising their exacting performance. To minimize damage and risk of injury, the following should be done:

• Inspect the instrument case and instruments for damage upon receipt and after each use and cleaning. Incompletely cleaned instruments should be re-cleaned. Instruments in need of repair should be set aside for repair service or returned to Biomet (Instruments returned to Biomet or its distributors should be cleaned and sterilized prior to shipment. ANSI/AAMI ST35 Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings provides guidelines for return, or contact Biomet or your distributor for further instruction).

• Only use an instrument for its intended purpose. • When handling sharp instruments use extreme caution to avoid injury. Consult

with an infection control practitioner to develop and verify safety procedures appropriate for all levels of direct instrument contact.

2. General Cleaning. Clean instruments prior to initial sterilization and as soon as possible after use. Do not allow blood or debris to dry on the instruments. If cleaning must be delayed, place groups of instruments in a covered container with appropriate detergent or enzymatic

solution to delay drying. Wash all instruments whether or not they were used or inadvertently came into contact with blood or saline solution.

3. Ultrasonic Cleaners can be used with hot water per manufacturer’s recommended tem-perature (usually 90º-140ºF or 32º-60ºC) and specially formulated detergents. Follow manu-facturer’s recommendations for proper cleaning solution formulated specifically for ultrasonic cleaners. Be aware that loading patterns, instrument cassettes, water temperature, and other external factors may change the effectiveness of the equipment.

4. Washer-Decontamination Equipment will wash and decontaminate instruments. Complete removal of soil from crevices and serrations depends on instrument construction, exposure time, pressure of delivered solution, and pH of the detergent solution, and thus may require prior brushing. Be familiar with equipment manufacturers’ use and operation instructions. Be aware that loading, detergent, water temperature, and other external factors may change the effectiveness of the equipment.

RESPONSIBILITIES OF THE USERGeneral. Health care personnel bear the ultimate responsibility for ensuring that any packaging method or material is suitable for use in sterilization processing and sterility maintenance.

Cleaning/Decontamination. The health care facility is responsible to insure that conditions es-sential to safe handling and decontamination can be achieved. ANSI/AAMI ST35 Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings provides guidelines for design and personnel considerations, immediate handling of contaminated items and transportation, decontamination processes, servicing, repair, and process performance.

Sterility. Users should conduct testing in the health care facility to ensure that conditions es-sential to sterilization can be achieved and that specific configuration of the container contents is acceptable for the sterilization process and for the requirements at the point of use. ANSI/AAMI ST33 Guidelines for the Selection and Use of Reusable Rigid Container Systems for Ethylene Oxide Sterilization and Steam Sterilization in Health Care Facilities covers the selection and use of reusable rigid sterilization container systems. Guidelines are provided by this standard for clean-ing and decontamination, preparation and assembly, sterilizer loading and unloading, matching the container system to the appropriate sterilization cycle, quality assurance, sterile storage, transport, and aseptic use.

WARNINGS AND PRECAUTIONSUnless otherwise indicated, instrument sets are NOT sterile and must be thoroughly cleaned and sterilized prior to use.

Instruments should NOT be flash-autoclaved inside the instrument case. Flash-autoclaving of individual instruments should be avoided.

Unwrapped instrument cases DO NOT maintain sterility.

A cannula set needs to be repaired and/or replaced when the fluid flow through the cannula around the scope is decreased.

STORAGE AND SHELF LIFEInstrument cases that have been processed and wrapped to maintain sterility should be stored in a manner to avoid extremes in temperature and moisture. Care must be exercised in handling of wrapped cases to prevent damage to the sterile barrier. The health care facility should establish a shelf life for wrapped instrument cases based upon the type of sterile wrap used and the recom-mendations of the sterile wrap manufacturer. The user must be aware that maintenance of sterility is event-related and that the probability of occurrence of a contaminating event increases over time, with handling, and whether woven or non-woven materials, pouches, or container systems are used as the packaging method.

STERILITYUnless otherwise indicated, instruments are NOT STERILE and must be thoroughly cleaned and sterilized prior to use.

Biomet® instruments can be steam autoclaved and repeated autoclaving will not adversely affect them, unless otherwise indicated in the labeling. If you have any problems when using Biomet® instruments or instrument cases, please bring this to Biomet’s or Biomet’s distributor’s attention when you return them. (Instruments returned to Biomet or its distributors should be cleaned and sterilized prior to shipment. ANSI/AAMI ST35 Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings provides guidelines for return or contact Biomet or your distributor for further instruction).

Unless supplied sterile, instruments must be thoroughly cleaned and sterilized prior to surgical use. Set forth below is a recommended minimum cycle for steam sterilization that has been validated by Biomet under laboratory conditions. Individual users must validate the cleaning and autoclaving procedures used on-site, including the on-site validation of the recommended mini-mum cycle parameters described below.

Surgical instruments may be autoclaved using a full cycle. Instruments that have been used in a surgical environment should be thoroughly cleaned prior to autoclaving. Use of ANSI/AAMI ST46 Steam Sterilization and Sterility Assurance in Health Care Facilities is recommended. The following cycle parameters are the minimum for instrument cases up to 25 lbs (11 kgs).

GRAVITY DISPLACEMENT STERILIZER (Full Cycle)270º - 275º F (132º - 135º C) – Double or Single Wrapped or unwrapped 12 minutes exposure time - 8 minutes drying time.

PRE-VACUUMED STERILIZER (HI-VAC)270º - 275º F (132º - 135º C) – Double or Single Wrapped or unwrapped 5 minutes exposure time - 8 minutes drying time.

Multi-Level Instrument CasesIn some instrument case designs, two or three individual instrument cases may be supplied with an outer transportation container. These instrument cases may be sterilized individually following the instructions above, or may be sterilized by placing the individual cases within the supplied transportation container. To sterilize two or three instrument cases within the supplied outer trans-portation container, the following sterilization cycle parameters are recommended. The following cycle parameters are the minimum for instrument cases up to 35 lbs. (16 kgs.).

49

The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Biomet at the contact information provided herein.

PRE-VACUUMED STERILIZER (HI-VAC)270°- 275° (132° - 135°C) – Double or Single Wrapped or unwrapped 10 minutes exposure time – 8 minutes drying time.

Since Biomet is not familiar with individual hospital handling procedures, cleaning methods, bio-burden levels, and other conditions, Biomet assumes no responsibility for sterilization of product by a hospital even if the general above guidelines are followed.

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Comments regarding Biomet® devices or instruments can be directed to Attn: Regulatory Dept., Biomet, Inc., P.O. Box 587, Warsaw, IN 46581 USA, FAX: 574-372-3968.

Biomet® and all other trademarks herein are the property of Biomet, Inc. or its subsidiaries.

Authorized Representative: Biomet U.K., Ltd. Waterton Industrial Estate, Bridgend, South Wales CF31 3XA, U.K.

0086

CLEANING AND STERILIZATION METHODS

Biomet® Rigid Instrument Cases - Suitable for Steam AutoclavingAluminum, Stainless Steel, and Polymeric

Processing Steps Suggested Method

Removal of gross contamination & disassembly By hand submerged in water with continuous flow with mechanical aid (e.g. brush) wearing protective gloves & goggles

Disassemble instruments into individual parts

Washing & Disinfecting Automatic washer-disinfection unit utilizing thermal disinfection (ultrasonic or continuous tunnel process preferable) – Temperatures, cycles & disinfectant type used as instructed by manufac-turer of washer-disinfection unit

Sterilization Steam autoclave

Steam Autoclave Cycle Parameters*Gravity Displacement Sterilizer (Full Cycle)270º-275º F (132º-135º C) - Double or Single Wrapped or unwrapped 12 minutes exposure time – 8 minutes drying time

Pre-Vacuumed Sterilizer (HI-VAC)270º-275º F (132º - 135º C) - Double or Single Wrapped or unwrapped 5 minutes exposure time – 8 minutes drying time

*Validated by Biomet under laboratory conditions; however, these cycles must be re-validated by the end-user to ensure that sterility can be achieved on site.

Precautions When handling sharp instruments use extreme caution to avoid injury. Consult with an infection control practitioner to develop and verify safety procedures appropriate for all levels of direct instrument contact.

Unless otherwise indicated, instrument sets are NOT Sterile and must be thoroughly cleaned and sterilized prior to use.

Instruments should NOT be flash-autoclaved inside the instrument case. Flash-autoclaving of individual instruments should be avoided, whenever possible.

Unwrapped instrument cases DO NOT maintain sterility.

Manufacturer

Date of Manufacture

Do Not Reuse

Caution, Consult Accompanying Documents

Sterilized using Ethylene Oxide

Sterilized using Irradiation

Sterile

Sterilized using Aseptic Technique

Sterilized using Steam or Dry Heat

Use By

WEEE Device

Catalogue Number

Batch Code

Flammable

Authorized Representative in the European Community

Symbol Legend

Manufacturer

Date of Manufacture

Do Not Reuse

Caution



Sterile

Sterilized using Aseptic Processing Techniques


Use By

WEEE Device

Catalogue Number

Batch Code

Flammable

Authorised Representative in the European Community

Symbol Legend

50

Biomet Orthopedics 01-50-0975 P.O. Box 587 Date: 11/09 56 East Bell Drive Warsaw, Indiana 46581 USA

BIOMET® KNEE JOINT REPLACEMENT PROSTHESES

ATTENTION OPERATING SURGEON

DESCRIPTIONBiomet manufactures a variety of knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components. Components are available in a variety of designs and size ranges intended for both primary and revision applications. Specialty components are available including; femoral stems, femoral augments, tibial stems, tibial augments, tibial cement plugs and tibial screws.

MATERIALSFemoral Components CoCrMo Alloy/Titanium AlloyTibial Plates CoCrMo Alloy/Titanium AlloyTibial Bearings Ultra-High Molecular Weight Polyethylene (UHMWPE)Patellar Components UHMWPE/Titanium Alloy/316LVM Stainless SteelFemoral Stems Titanium AlloyAugment Components Titanium AlloyStem Components Titanium AlloyTibial Cement Plugs UHMWPETibial Screws Titanium AlloyModular Pegs CoCrMo Alloy

INDICATIONS 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic

arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint

replacement procedure.

The Regenerex™ femoral augments are indicated for use with the Vanguard™ Total Knee System.

The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.

Patient selection factors to be considered include: 1) need to obtain pain relief and improve function, 2) ability and willingness of the patient to follow instructions, including control of weight and activity level, 3) a good nutritional state of the patient, and 4) the patient must have reached full skeletal maturity.

Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok™) devices and all-polyethyl-ene patellar components are indicated for cemented application only.

CONTRAINDICATIONSAbsolute contraindications include: infection, sepsis, and osteomyelitis.Relative contraindications include: 1) an uncooperative patient or a patient with neurologic dis-orders who is incapable of following directions, 2) osteoporosis, 3) metabolic disorders which may impair bone formation, 4) osteomalacia, 5) distant foci of infections which may spread to the implant site, 6) rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, 7) vascular insufficiency, muscular atrophy, neuromuscular disease, and/or 8) incomplete or deficient soft tissue surrounding the knee.

Biomet® Microplasty™ Tibial Trays are contraindicated for use with constrained bearings.

WARNINGSImproper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components. Malalignment of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or procedure. Inadequate preclosure cleaning (removal of surgical debris) can lead to excessive wear. Use clean gloves when handling implants.

Laboratory testing indicates that implants subjected to body fluids, surgical debris or fatty tissue have lower adhesion strength to cement than implants handled with clean gloves. Improper preoperative or intraoperative implant handling or damage (scratches, dents, etc.) can lead to crevice corrosion, fretting, fatigue fracture and/or excessive wear. Do not modify implants. The surgeon is to be thoroughly familiar with the implants and instruments prior to performing surgery.

1. The 23mm Single-Peg Patella components should be used only with an inset mill surgical technique. Product numbers for the 23mm Single-Peg Patella components include the fol-lowing: CP112895, CP112896, and CP112897.

2. The shorter titanium locking screws, Catalogue Number 7700015B (Performance Locking Screw), is to be used with the cruciate-retaining and cruciate-supplementing articulating surfaces. The longer P/S Locking Screw, Catalogue Number 7900015B (Performance P/S Locking Screw), is to be used with the P/S cruciate and constrained substituting articulating surface.

3. The locking bar used to secure the tibial plate and tibial-bearing components together must lock securely into place with an audible click at the time of implantation. Disassociation of the locking bar from the modular tibial plate component has been reported. Inadequate seating of the locking bar can cause disassociation of the locking bar from the tibial plate compo-nent, requiring revision surgery.

4. The 8mm-polyethylene insert of the modular tibial is not compatible with the AGC™ posterior stabilized and revision AGC™ femoral components. Product numbers for the 8mm-polyeth-ylene insert bearing components include the following: 155508, 155608, 155628, 155648, 155668, 155688, 155708, 155728, and 155748.

5. The all-polyethylene tibial component is designed to be used in treatment of low demand, less active sedentary patients. Patients that will remain active and/or overweight are not candidates for all- polyethylene tibial components.

6. Malalignment or soft tissue imbalance can place inordinate forces on the components, which may cause excessive wear to the patellar or tibial bearing articulating surfaces. Revision surgery may be required to prevent component failure.

7. Care is to be taken to assure complete support of all parts of the device embedded in bone cement to prevent stress concentrations, which may lead to failure of the procedure.

Complete preclosure cleaning and removal of bone cement debris, metallic debris, and other surgical debris at the implant site is critical to minimize wear of the implant articular surfaces.

Implant fracture due to cement failure has been reported. 8. It is the responsibility of the operating surgeon to determine whether there is adequate initial

fixation and stability. Stem extension and bone cement are available if additional fixation or stability are needed.

9. The Regenerex™ Tibial Trays require a stem when used with PS components.

Biomet® joint replacement prostheses provide the surgeon with a means of reducing pain and restoring function for many patients. While these devices are generally successful in attaining these goals, they cannot be expected to withstand the activity levels and loads of normal healthy bone and joint tissue.

Accepted practices in postoperative care are important. Failure of the patient to follow postopera-tive care instructions involving rehabilitation can compromise the success of the procedure. The patient is to be advised of the limitations of the reconstruction, and the need for protection of the implants from full load bearing until adequate fixation and healing have occurred. Excessive activity, trauma and excessive weight have been implicated with premature failure of the implant by loosening, fracture, and/or wear. Loosening of the implants can result in increased production of wear particles, as well as accelerate damage to bone, making successful revision surgery more difficult. The patient is to be made aware and warned of general surgical risks, possible adverse effects as listed, and to follow the instructions of the treating physician including follow-up visits.

PRECAUTIONSSpecialized instruments are designed for Biomet® joint replacement systems to aid in the accurate implantation of the prosthetic components. The use of instruments or implant components from other systems can result in inaccurate fit, sizing, excessive wear and device failure. Intraoperative fracture or breaking of instruments has been reported. Surgical instruments are subject to wear with normal usage. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. Surgical instruments should only be used for their intended purpose.

Biomet recommends that all instruments be regularly inspected for wear and disfigurement.

Do not reuse implants. While an implant may appear undamaged, previous stress may have created imperfections that would reduce the service life of the implant. Do not treat patients with implants that have been, even momentarily, placed in a different patient.

POSSIBLE ADVERSE EFFECTS 1. Material sensitivity reactions. Implantation of foreign material in tissues can result in histologi-

cal reactions involving various sizes of macrophages and fibroblasts. The clinical significance of this effect is uncertain, as similar changes may occur as a precursor to or during the healing process. Particulate wear debris and discoloration from metallic and polyethylene components of joint implants may be present in adjacent tissue or fluid. It has been reported that wear debris may initiate a cellular response resulting in osteolysis, or osteolysis may be a result of loosening of the implant.

2. Early or late postoperative infection and allergic reaction. 3. Intraoperative bone perforation or fracture may occur, particularly in the presence of poor

bone stock caused by osteoporosis, bone defects from previous surgery, bone resorption, or while inserting the device.

4. Loosening or migration of the implants can occur due to loss of fixation, trauma, malalign-ment, bone resorption or excessive activity.

5. Periarticular calcification or ossification, with or without impediment of joint mobility. 6. Inadequate range of motion due to improper selection or positioning of components. 7. Undesirable shortening of limb. 8. Dislocation and subluxation due to inadequate fixation and improper positioning. Muscle and

fibrous tissue laxity can also contribute to these conditions. 9. Fatigue fracture of component can occur as a result of loss of fixation, strenuous activity,

malalignment, trauma, non-union, or excessive weight. 10. Fretting and crevice corrosion can occur at interfaces between components. 11. Wear and/or deformation of articulating surfaces. 12. Valgus-varus deformity. 13. Transient peroneal palsy secondary to surgical manipulation and increased joint movement

has been reported following knee arthroplasty in patients with severe flexion and valgus deformity.

14. Patellar tendon rupture and ligamentous laxity. 15. Interoperative or postoperative bone fracture and/or postoperative pain.

STERILITYProsthetic components are sterilized by exposure to a minimum dose of 25 kGy of gamma radia-tion. Do not resterilize. Do not use any component from an opened or damaged package. Do not use implants after expiration date.

Caution: Federal law (USA) restricts this device to sale, distribution, or use by or on the order of a physician.

Comments regarding the use of this device can be directed to Attn: Regulatory Affairs, Biomet, Inc., P.O. Box 587, Warsaw, IN 46581 USA, Fax: 574-372-3968.

Biomet® and all other trademarks herein are the property of Biomet, Inc. or its subsidiaries.

Authorized Representative: Biomet U.K., Ltd. Waterton Industrial Estate Bridgend, South Wales CF31 3XA UK

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Symbol Legend

The information contained in this package insert was current on the date this brochure was printed. However, the package insert may have been revised after that date. To obtain a current package insert, please contact Biomet at the contact information provided herein.

Symbol Legend

Manufacturer

Date of Manufacture

Do Not Reuse

Caution



Sterile

Sterilized using Aseptic Processing Techniques


Use By

WEEE Device

Catalogue Number

Batch Code

Flammable

Authorised Representative in the European Community

3


Notes

4


Notes

All trademarks herein are the property of Biomet, Inc. or its subsidiaries unless otherwise indicated.

This material is intended for the sole use and benefit of the Biomet sales force and physicians. It is not to be redistributed, duplicated or disclosed without the express written consent of Biomet.

For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert herein and Biomet’s website.

P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 x 1501 ©2010–2011 Biomet Orthopedics • biomet.com

Form No. BOI0429.1 • REV061511

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