Orthopaedic Devices | Hip | Knee | Shoulder - …...total knee procedures. Symptoms include, but are...

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Zimmer ® CAS eLIBRA ® Dynamic Knee Balancing System (DKBS) Surgical Technique

Transcript of Orthopaedic Devices | Hip | Knee | Shoulder - …...total knee procedures. Symptoms include, but are...

Page 1: Orthopaedic Devices | Hip | Knee | Shoulder - …...total knee procedures. Symptoms include, but are not limited to, lateral knee pain, instability while ascending or descend-ing stairs,

Zimmer® CAS eLIBRA® Dynamic Knee

Balancing System

(DKBS)

Surgical Technique

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SECTION Page

Table of Contents

System Overview 4

Surgical Techniques 4

Device Design 4

Design Rationale 5

Preoperative Planning 6

Device Details 6

Component Sizing Compatibility 6

Activating the Sensor 6

Readings and Measures 7

Surgical Technique Workflow 7

Balance in Extension 7

Balance in Flexion 8

STEP 1: Extension Gap & Limb Alignment 8

STEP 2: LIBRA Femoral Placement 8

Step 3: Select and Insert Tibial Insert 9

STEP 4 : Establish Dynamic Knee Balance 11

Step 5: Placement of the 4-in-1 Resection Guide 12

Trial Reduction Technique 15

Step 1: Place femoral provisional on the Femur 15

Step 2: Select and Place Sensor into Joint Space 15

Step 3: Once Balanced in Flexion, bring Knee into Extension 15

Appendix A - Magnetic Augments 17

Catalog Information - Disposable Part Numbers 19

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System Overview

The eLIBRA System is a dynamic knee balancing system that uses an electronic force measurement device and an adjustable femoral component device to establish a sym-metrical flexion gap via balanced resection. It is designed to improve post-operative stability, patellar tracking, and ROM by enhancing the repeatability and accuracy of soft-tissue balancing.

Surgical TechniquesThe eLIBRA DKBS is intended for use either uniquely for balancing in extension, balancing in flexion, or during trial reduction. It may also be used in combination as described in the full surgical technique below.

When used in extension, the system helps examine the condition and symmetry of the soft tissue and evaluate the impact of soft tissue releases on the alignment of the knee.

When used in flexion, the system is designed to externally rotate the femoral component such that it will be in kinematic harmony with the surrounding soft tissues, enhancing patellar tracking and ROM.

When used for trial reduction, the system helps determine tibial insert thickness prior to inserting the provisional implants, in efforts to mitigate global flexion instability. It is designed for use after the liga-ments have been balanced in extension and in flexion and after all cuts have been made and femoral trials are in place.

Device Design The eLIBRA DKBS works with the implant system

instruments to establish femoral component rotation, gap symmetry, and joint tension. Instrument sets are specific to the implant system due to variations in implant design, i.e. femoral component and poly thicknesses, anterior/posterior reference, etc. This system may be used in conjunction with the standard NexGen® Knee, NexGen CR-Flex and NexGen LPS Flex Knee Systems and the standard Natural-Knee® II and the Gender Solutions® Natural-Knee Flex Systems.

This system accommodates for patient variability. It offers personalized clinically relevant solutions when managing difficult varus/valgus knees, asymmetric flexion gaps, and assessing patella tracking, femoral rotation, and flexion stability.

This system was designed to avoid inconsistencies that may occur in the standard technique when relying on empirical bony-landmarks1. The eLIBRA DKBS helps neutralize these surgical technique variabilities.

The eLIBRA DKBS allows soft tissue to dictate optimal femoral component position while patellar femoral kinematics improve2. This system assists in evaluating patellar tracking prior to finishing femoral bone cuts.

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Design RationaleFemoral malrotation3, flexion instability4 and improper patella tracking5 are three of the most common causes of revision total knee procedures. Symptoms include, but are not limited to, lateral knee pain, instability while ascending or descend-ing stairs, and a feeling of the knee “slipping”. In total knee arthroplasty, two parallel cuts are obtained in extension to create a rectangular extension gap. To reproduce a symmetrical rectangular gap in flexion and to accommodate for the angle of the proximal tibial resection, an appropriate external rotation of the femoral component needs to be performed. It has been shown that the three traditional anatomic femoral landmarks used to determine femoral component rotation may lead to inaccuracies in component positioning. Posterior condylar axis, Whiteside’s line and the transepicondylar axis were shown to create inaccurate flexion gap symmetry, from 10 to 50 percent of the time1. The eLIBRA DKBS offers a measurable approach that accommodates variation in the patients’ soft tissue envelope, taking into account the angle of the tibial resection, and is designed to allow for consideration of optimal patellar tracking.

1. Olcott, C.W., Scott, R.D. A comparison of 4 intraoperative methods to determine femoral component rotation during total knee arthroplasty: The Journal of Arthroplasty, 2000; Vol 15, No 1:22-26.2. Miller, M. et al Optimizing femoral component rotation in total knee arthroplasty: Clinical Orthopaedics and Related Research, 2001: No. 392: 38-45.3. Incavo, Steven J., MD, and John J. Wild, MD. “Early Revision for Component Malrotation in Total Knee Arthroplasty.” Clinical Orthopaedics and Related Research. No. 458 (2007): pp. 131–136. 4. Fehring, Thomas K., MD, and Alan L. Valadie, MD. “Knee Instability After Total Knee Athroplasty.” Clinical Orthopaedics and Related Research. No. 299 (1994): pp. 157–162. 5. Malo, Michel, MD, and Vince, Kelly G., MD. “The Unstable Patella After Total Knee Arthroplasty: Etiology, Prevention, and Management.” The Journal of the American and Orthopaedic Surgeons. Vo. 11. No. 5 (2003).

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Preoperative Planning

The eLIBRA DKBS does not require specific preoperative consideration other than component sizing as stated below.

Device Details

Component Sizing CompatibilityWhen using the eLIBRA DKBS, the size of the LIBRA® femo-ral component should always match the size of the dispos-able sensor (i.e. small sensor with small femur).

Small eLIBRA Sensor Large eLIBRA Sensor

NexGen tibia 3,4,5,6 7 to 10

Natural-Knee II Tibia 1,2,3 4,5

Activating the Sensor Pull the activation tab to activate the sensor, removing it from the device. Remove the strip by pulling the tab in the direction of the arrow. Pull straight to avoid tearing the activation tab. Once removed, the activation tab can be discarded. The device has been activated when “SYNVA-SIVE” is briefly shown on the display, followed by values. The eLIBRA sensor remains active for a minimum of ap-proximately 3 hours.

Note: A non-operative force, generated by applying finger force to the Force Pad, can be applied prior to inserting into the knee joint to assure activation. When the Display is op-erational the numbers will freely change as varying forces are applied. The Display readout will automatically adjust for the RIGHT/LEFT surgical use.

Caution: Do not use this device if it appears to be mal-functioning based on the instructions.

Warning: When activating the eLIBRA Soft Tissue Force Sensor, firmly grab the activation tab and pull straight up. Never pull on the tab in any oth-er manor or direction, the tab may become dam-aged and the device rendered useless.

Two sizes of electronic force sensors are available, small and large. The small sensors are white and the large sen-sors are blue.

Zimmer Prod. No. Description

20-8012-000-01 eLIBRA SOFT TIS FORC SENSR SML

20-8012-000-02 eLIBRA SOFT TIS FORC SENSR LGE

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Readings and Measures

The sensors have force transducers on the medial and lateral side that register values onto the screen.

Each number (1 thru 20) represents approximately 15 Newtons (3.4 lbs of force).

The device does NOT measure pressure or tension.

By design, the LIBRA femoral component holes are off-set. The lateral hole is 1.5mm higher to allow for a fixed amount of lateral laxity. This design accommodates the screw home mechanism. Therefore, readings in the trial reduction technique may differ from readings at ligament balancing.

Surgical Technique Workflow

Balance in ExtensionIn extension, the system helps examine the pull of the soft tissue and evaluate the impact of soft tissue releases on the stability of the knee. The disposable sensor accepts different thicknesses of spacer paddles.

With the tibial proximal cut and the femoral distal cut per-formed, choose the appropriate side (Right/Left) and size of the eLIBRA disposable sensor (Small/Large) (20-8012-000-01/20-8012-000-02) (for more information on sizing, see the ‘Component Sizing Compatibility’ section). Power on the eLIBRA sensor (for activation instructions, see the ‘activating the sensor’ section).

Place the eLIBRA disposable sensor onto the appropriate Spacer Paddle (8, 10 mm, 12mm, 14mm) and secure it into the grooves. Spacer Paddle Thickness (8, 10, 12, 14, and 17mm (12mm + 5mm Step-Up Adapter) is used to bal-ance extension and assess relative medial/lateral forces. Insert the spacer paddle and the eLIBRA sensor assembly into the joint space. Start by using the assembly thickness that matches the space created by your distal femur and proximal tibial cuts.

Insert the eLIBRA sensor and spacer paddle assembly into the joint space. If the thinnest spacer cannot be inserted, check for osteophytes, posterior capsular tightness, menis-cal remnants or reassess the distal femur and/or tibial resection. Position the leg so that the two cuts are parallel, this is achieved by slightly flexing the leg. Typically, the medial readings in extension are higher than the medial readings in flexion.

Once the spacer paddle in extension has been used for balancing, start with the equivalent tibial insert when ap-plying the eLIBRA DKBS in flexion, i.e., if a 10mm spacer was used in extension, use the 10 mm tibial insert to start with in flexion.

Warning: Every surgeon will have their own preference as to what level of stability is prescribed for each individual patient. The eLIBRA system allows for personalized op-tions, while giving an objective means to assure accurate reproducibility.

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Balance in FlexionIn flexion, the system is designed to externally rotate the femoral component such that it will be in proper orienta-tion with the surrounding soft tissues and the location of the patellar component.

STEP 1: Extension Gap & Limb AlignmentOnce the distal femoral and proximal tibial resections are completed, balance the knee by establishing the exten-sion gap with either the spacer paddle technique or other implant-specific techniques.

STEP 2: LIBRA Femoral PlacementSelect the appropriate LIBRA Femoral Component size (Small/Large) and side (Right/Left) based on the selected sensor size (for more information on sizing, see the ‘Com-ponent Sizing Compatibility’ section) and implant used (NexGen, Natural-Knee). Match the femoral component size to the sensor size selected.

Warning: The eLIBRA sensor size should always correspond to the LIBRA femoral component size used (Large with Large, Small with Small). Undesirable force readings may be displayed if the sensor and femoral component sizes do not match.

Secure the LIBRA Femoral Component against the distal femur and posterior condyles ensuring flush contact with the distal femur. Before seating the LIBRA femoral compo-nent, assure the lateral skid is closed. To close the lateral skid, use the Green T-Handle (20-8012-010-22), insert it in the adjustment mechanism and turn counter-clockwise until closed.

Note: - Assess both varus/valgus deformities and flexion/exten-sion contractures.

- Remove all medial and lateral osteophytes from the border of the femur to avoid ligament “tenting.”

- Posterior osteophytes and meniscal remnants must be re-moved to ensure proper positioning of the LIBRA Femoral Component.

Note: For a posterior stabilized knee prosthesis, remove the PCL before proceeding to any force readings with the eLIBRAdevice. Balancing should be performed after PCL sacrifice.

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Zimmer® CAS eLIBRA® Dynamic Knee Balancing System (DKBS)Surgical Technique

Step 3: Select and Insert Tibial InsertOnce the correct femoral placement is achieved, activate the corresponding size sensor (for activation instructions, see the ‘Activating the Sensor’ section).

The disposable sensor accepts different thicknesses of tibial inserts for use in flexion with the LIBRA femoral com-ponent of the same size. An eLIBRA Tibial Insert is selected and assembled to the active sensor. Select the initial insert thickness according to extension gap evaluation in the preceding step.

When choosing the initial insert thickness, begin with the size that is most compatible with the extension space measurement. Left/Right knee orientation is selected by attaching the insert to the surface of the sensor which indicates “RIGHT KNEE” or “LEFT KNEE”.

To confirm this, the handle and display on the sensor will protrude medially through the incision. The insert rests on the sensor; no snap is required. Insert the two tabs under the insert into the two slots on the electronic force sensor.

Warning: Never bend or torque the handle of the eLIBRA Soft Tissue Force Sensor when inserting, repositioning, or removing the device from the joint space. Damage may occur rendering the sensor useless.

Center the LIBRA femoral component with respect to the trochlear notch and position it off of the most proud surface of the posterior femoral condyles. Position the adjustment mechanism anterior-medial to the positioned patella. Secure the LIBRA Femoral Component with two fixation screws.

Two different screw sizes are available. If preferred, sterile screws are also available. The screw/driver combination is:

Zimmer Part No. Description

20-8012-010-23 LIBRA MPin DRV MULTU 2.5mm Hex

20-8012-010-24 LIBRA Fixation Screw 32mm

20-8012-010-25 LIBRA Fixation Screw 42mm

Sterile screw combinationZimmer Part No. Description

20-8012-000-04 LIBRA Fixation Screw Kit 32mm

20-8012-000-03 LIBRA Fixation Screw Kit 42mm

20-8012-010-23 LIBRA MAG PDRV MULT U 2.5mmHex

Use a power drill and the magnetic driver (20-8012-010-23) to drive the screws in ¾ of the way and finish tighten-ing the screws with the eLIBRA Blue T-handle (20-8012-010-26).

Note: If there is a posterior condylar deficiency of � 4mm, a magnetic augment can be used to fill the deficiency, please refer to Appendix A.

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1. Insert eLIBRA Tibial Insert assembly into joint space

When inserting the assembly, insert using thumb and forefinger to hold the two pieces together, this prevents separation. Flex the leg to 60˚ where the insertion meets less resistance. Slide the assembly into the joint space tak-ing proper care to seat the assembly as far back posteriorly as the soft tissues will allow. If an insert height of greater than 13mm is required, use the matching size (small or large) 5 mm Tibial Insert Step-Up Adapter (20-8012-010-21/20-8012-010-19).

Note: If the thinnest eLIBRA Tibial Insert cannot be inserted into the joint space re-examine the following: - Examine structures causing posterior capsule tightness, remove any osteophytes

- Consider amount of slope and proximal tibial resection

- Remove any remaining components of the menisci

- If soft tissue management does not facilitate insertion with the knee in flexion, consider additional proximal tibial re-section to gain sufficient access.

2. Reduce patella making sure all dynamic forces are considered

Keep the sensor display pointed medially to ensure the patella can be reduced without interference.

3. With the Force Sensor active and in place, put the knee in 90° of flexion

Raise the femur (avoid lifting the tibia) making sure not to influence any structures in the posterior capsule

Use a towel as a sling to cradle under the achilles to prevent varus/valgus bias on the collateral ligaments of the knee.

Lift the sling/tibia to 90° of flexion

4.Examine the medial load indicated by the number on the electronic display.

Posterior condyles engage in the grooves of the insert at 90° of flexion. When target medial number is achieved, proper insert height is established. Typically, medial force numbers will be higher than lateral force numbers, and adjustment of the articulating LIBRA femoral component with the Green T-Handle can now begin.

The desired balance point should create equal relative compartment forces. Rotation is chosen based on the amount of force that is found and equalized in both the medial and lateral compartments.

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Zimmer® CAS eLIBRA® Dynamic Knee Balancing System (DKBS)Surgical Technique

STEP 4 : Establish Dynamic Knee BalanceInsert the green eLIBRA T-handle (20-8012-010-22) into the adjustment mechanism on the anterior medial side of the femoral component, rotating clockwise, to elevate the lateral condyle and balance the relative compartment forces (until both readings are equal).

Rotating clockwise elevates the skid positioned under the posterior lateral condyle and results in additional external rotation of the femoral component. As the posterior lateral space is opened, a minimum of 0° to a maximum of 10° of external rotation in relation to the posterior condyles can be achieved.

The LIBRA Femoral Component should function as an ar-ticulating spacer with articulation acting similar to implant trials. Always verify the balanced position by articulating the knee and observing the patella tracking.

Only begin rotating the dial once the medial number reads greater or equal to 4 to achieve stability at 90° of flexion. The medial collateral must be challenged to provide the necessary elastic response. The reading must be larger medially than laterally. Typical readings observed on the medial side range from 4-8, assuring the MCL is respon-sive.

( g q )

Rotating clockwise elevates the skid positioned under the

If the sensor reads less than 4 on the medial side, in-sert the next thickest tibial insert. Insert thicker inserts until a medial number reads greater or equal to 4.

If the medial number being displayed is greater than the lateral number, begin rotating the medial dial until the two numbers reach equality.

If the medial number is greater than 9 reduce insert thickness.

If the medial number is greater than 9 with the thin-nest insert in place, consider additional soft-tissue management, additional tibial resection, or re-assess tibial varus angle.

If the lateral number being displayed is greater than the medial number, consider/examine the following:

1. Verify that the medial collateral ligament is functional

2. Re-examine varus/valgus of tibial resection; tighter lateral side could indicate a tibial resection made in varus.

Once the rotation has been established in flexion using the LIBRA femoral component and the eLIBRA disposable sen-sor, the 2 holes of the LIBRA femoral component are drilled to reference the measured rotation. Drill the two holes through the LIBRA Femoral Component using a Steinman pin or comparable 3.2mm drill bit (1/8 inch).

Remove the LIBRA Femoral Component, force sensor, and tibial insert.

Warning: Surgeons may want to take other factors (such as additional anatomical landmarks) into consideration when determining external rotation.

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Step 5: Placement of the 4-in-1 Resection GuidePlace the implant specific LIBRA Adapter or Sizer onto the femur. Refer to the Zimmer NexGen Systems (5.1,5.2) or Natural-Knee II Systems (5.3,5.4) section that follow for more guidelines on the implant specific techniques.

Step 5.1: A/P Placement of 4-in-1 Resection Guide – Anterior Referencing

Standard NexGen Knee System, NexGen CR-Flex and Nex-Gen LPS Flex Knee Systems

Place the NexGen LIBRA Adapter Sizing jig (20-8012-010-05) onto the distal femur into the previously drilled femoral rotation holes. The Sizer is used to size the femoral implant and drill the pin holes for the appropriate 4-in-1 cutting block size (see image below). Use the LIBRA Introducer (20-8012-010-07) to position the adapter block.

Establish the A/P position of the cutting guide according to the femoral size. Drill the two implant positioning holes with the implant system twist drill. Remove the jig using the introducer (20-8012-010-07), leaving the M/L pins in place.

Step 5.2: A/P Placement of 4-in-1 Resection Guide – Posterior Referencing

Size the femur with the Posterior Referencing Sizer (00-5901-040-00) as per implant surgical technique. The Posterior Referencing Sizer is only used to size the femur at this point, as femoral component rotation holes have already been established by the eLIBRA DKBS.

Introducer fits in anchoring plates.

ce.

Caution: When removing the anterior reference sizing guide, rotate the stylus 90 degrees to prevent any ob-struction from the anterior flare.

Place the corresponding 4-in-1 resection guide over the remaining drill pins and femoral rotation established by the eLIBRA DKBS. Prepare and finish the femur and tibia as per standard implant surgical technique.per standard implant surgical technique.

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Zimmer® CAS eLIBRA® Dynamic Knee Balancing System (DKBS)Surgical Technique

Place the posterior reference adapter block (20-8012-010-06) on the distal femur and drill the 0, +2mm, or +4mm holes with the implant system twist drill. Remove the posterior reference adapter block.

Step 5.3: A/P Placement of 4-in-1 Resection Guide

Standard Natural-Knee II System

Size the femur with the Distal Femoral Drill Guide with the Sizing Caliper (6219-01-120) as per implant surgical technique.

Place the corresponding 4-in-1 resection guide into the previously drilled holes. Prepare and finish the femur and tibia as per standard implant surgical technique.

Position the LIBRA Adapter Block (20-8012-030-05) against the distal femur into the previously drilled femo-ral rotation holes. Drill the lugholes for positioning the Natural-Knee II 4-in-1 finishing block and remove the LIBRA Adapter Block.Adapter Block.

Place the corresponding 4-in-1 resection guide over the remaining drill pins and femoral rotation established by eLIBRA DKBS. Prepare and finish the femur and tibia as per standard implant surgical technique.

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Step 5.4: A/P Placement of 4-in-1 Resection Guide

Gender Solutions Natural-Knee Flex System

Size the femur with the Natural-Knee Flex Femoral Sizer (00-5413-010-03) as per implant surgical technique.

Position the LIBRA Adapter Block ZNK-Flex (20-8012-030-06) against the distal femur into the previously drilled femoral rotation holes.

Anterior and posterior shifts +/-2mm are available on the LIBRA ZNK-Flex Adapter block if desired to improve poste-rior flexion space.

Drill the lug holes for positioning the 4-in-1 finishing block and remove the LIBRA Adapter Block.

Place the corresponding 4-in-1 resection guide into the re-maining drill holes. Prepare and finish the femur and tibia as per standard implant surgical technique.

Introducer fits in A/P Positioning Drill Guide

(00-5413-010-03) as per implant surgical technique.

Position the LIBRA Adapter Block ZNK-Flex (20-8012-03006) i h di l f i h i l d ill d

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Trial Reduction Technique

This technique helps determine appropriate tibial insert thickness prior to inserting the provisional implants. It is designed for use after the ligaments have been balanced in extension and in flexion and after all cuts have been made and femoral trials are in place.

Step 1: Place femoral provisional on the Femur

If the eLIBRA sensor reads greater than 5 medially, or me-dial and lateral number are greater than 5 numbers apart, the MCL may be too tight in flexion. Consider a thinner poly insert, re-cutting tibia, and/or examine tibial cut varus/valgus and slope.

If the eLIBRA sensor reads less than 2 medially, the MCL may be too loose in flexion. Insert the next thickest poly insert. Insert thicker inserts until a medial number reads between 3-5.

Step 3: Once Balanced in Flexion, bring Knee into ExtensionStep 2: Select and Place Sensor into Joint Space

Select the appropriate side (Right or left) and size (Small or large) sensor (for more information on sizing, see the ‘Component Sizing Compatibility’ section).

Place the trial insert (select the size corresponding to the extension space established) onto the eLIBRA sensor and secure it into the grooves. If the sensor has not been used previously, power it on by removing the plastic tab (for activation instructions, see the ‘activating the Sensor’ section). If additional tibial insert height is necessary, use the appropriate small or large 5mm Step-Up Adapter (20-8012-010-21/20-8012-010-19).

Place the assembly into the joint space at 90° of flexion us-ing a sling under the Achilles (for more information on this technique, see Step 3 under ‘Balance in Flexion”). Balance throughout a full range of motion may also be examined.

into Extension

If flexion is balanced but full extension cannot be achieved, consider additional release of the posterior cap-sule and or cutting additional distal femur and subsequent A/P femoral bone cuts.

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Final Outcome of Trial Reduction: Example of Observed M/L Force Readings:

”4” medial and “2” lateral in flexion

”12” medial and “10” lateral in extension

Note: The above example indicates forces that shows the flexion gap loaded with enough insert thickness to generate approximately 60 Newtons of force on the medial side.

Forces on the medial side in extension have been observed to be up to 3X the forces observed on the medial side in flex-ion.

Warning: Every surgeon will have their own preference as to what level of stability is prescribed for each individual patient. The eLIBRA system allows for personalized op-tions, while giving an objective means to assure accurate reproducibility.

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Appendix A - Magnetic Augments

The eLIBRA Magnetic Augments address primary TKAs with posterior deficiencies as well as unicompartmental knee revi-sions. The spacers are available sterile in disposable packs and are available in thicknesses of 4, 5, 6, 7, 8 mm

eLIBRA Magnetic Augment for TKA with Posterior Condylar DeficienciesThe magnetic augment(s) may be used to fill posterior condylar deficiencies (� 4mm). Follow the standard procedure as described in the above sections.

Prior to fixating the LIBRA femoral component as described in ‘Step 2’, assess the posterior condylar deficiency and select the most appropriate augment thickness. Place the selected magnetic augment into the keyslot of the posterior femoral condyle of the LIBRA Femoral Component and follow the remaining of the procedure as described in the ‘Surgical Tech-nique Workflow’ in the ‘Balance in Flexion’ section.

Zimmer Part No. Qty in Pckg Description

20801200005 5 eLIBRA Magnetic Augment pck (4,5,6,7,8 mm)

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eLIBRA Magnetic Augment for Uni-Knee Revisions for TKA

STEP 1Remove the Unicompartmental Femoral Component and perform the distal femoral and proximal tibial resections as per standard technique.

STEP 2Measure the posterior condylar implant thickness with cement and select the augment to fill the missing bone. Place the selected magnetic augment into keyslot of poste-rior femoral condyle of LIBRA Femoral Component.

STEP 3Mount LIBRA Femoral Component onto cut distal femur and complete balancing as defined in the eLIBRA Dynamic Knee Balancing System.

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Catalog Information - Disposable Part Numbers Manuf. No. Zimmer Prod. No. Description Qty Description

61-9341 20-8012-000-01 eLIBRA Soft Tissue Force Sensor- Small 1

61-9351 20-8012-000-02 eLIBRA Soft Tissue Force Sensor- Large 1

25-0527 20-8012-000-03 LIBRA Fixation Screw Kit 42mm 2

25-0526 20-8012-000-04 LIBRA Fixation Screw Kit 32mm 2

61-9309 20-8012-000-05 eLIBRA Magnetic Augment pck 1 4,5,6,7,8 mm

No. Manuf. No. Zimmer Prod. No. Description

CAS100 61-9632 KT-8012-010-01 eLIBRA DKB SYS ZNG Small/Large

1 60-9407 20-8012-010-23 LIBRA MPin DRV MULTU 2.5mm Hex

2 500-5408-02 20-8012-010-25 LIBRA Fixation Screw 42mm (2)

3 500-5408-01 20-8012-010-24 LIBRA Fixation Screw 32mm (4)

4 60-9219 20-8012-010-26 eLIBRA Wrench 2.5mm Hex Female

5 60-9201 20-8012-010-22 Wrench T-Handle T-20

6 61-9064 20-8012-010-21 eLIBRA TIB INS SU ADPT SML 5mm

7 61-9063 20-8012-010-19 eLIBRA TIB INS SU ADPT LRG 5mm

8 61-8749-05 20-8012-010-18 eLIBRA UNIV TIB INSRT LRG 13mm

9 61-8749-04 20-8012-010-17 eLIBRA UNIV TIB INSRT LRG 12mm

10 61-8749-03 20-8012-010-16 eLIBRA UNIV TIB INSRT LRG 11mm

11 61-8749-02 20-8012-010-15 eLIBRA UNIV TIB INSERT LRG10mm

12 61-8749-01 20-8012-010-14 eLIBRA UNIV TIB INSERT LRG 9mm

13 61-8748-05 20-8012-010-13 eLIBRA UNIV TIB INSERT SML13mm

14 61-8748-04 20-8012-010-12 eLIBRA UNIV TIB INSERT SML12mm

15 61-8748-03 20-8012-010-11 eLIBRA UNIV TIB INSERT SML11mm

16 61-8748-02 20-8012-010-10 eLIBRA UNIV TIB INSERT SML10mm

17 61-8748-01 20-8012-010-09 eLIBRA UNIV TIB INSERT SML 9mm

18 60-9218 20-8012-010-08 LIBRA STER Tray Base With Tag

19 60-9215 20-8012-010-27 LIBRA Sterile Tray Lid

20 60-9203 20-8012-010-07 LIBRA Introducer

21 60-9012 20-8012-010-05 LIBRA Sizing Jig ZNG

22 60-4814 20-8012-010-04 LIBRA Fem COMP ZNG Large Left

23 60-4813 20-8012-010-03 LIBRA FEM COMP ZNG Large Right

24 60-4812 20-8012-010-02 LIBRA FEM COMP ZNG Small Left

25 60-4811 20-8012-010-01 LIBRA FEM COMP ZNG Small Right

Instrument Kits Part Numbers - Instrument Kit for S/L Zimmer NexGen Systems

Page 20: Orthopaedic Devices | Hip | Knee | Shoulder - …...total knee procedures. Symptoms include, but are not limited to, lateral knee pain, instability while ascending or descend-ing stairs,

Zimmer® CAS eLIBRA® Dynamic Knee Balancing System (DKBS)Surgical Technique

20

Instrument Kit for S/L Zimmer Natural-Knee Systems

No. Manuf. No. Zimmer Prod. No. Description

CAS102 61-9634 KT-8012-030-01 eLIBRA DKB ZNK SML/LRG

1 60-9407 20-8012-010-23 LIBRA MPin DRV MULTU 2.5mm Hex

2 500-5408-02 20-8012-010-25 LIBRA Fixation Screw 42mm (2)

3 500-5408-01 20-8012-010-24 LIBRA Fixation Screw 32mm (4)

4 60-9219 20-8012-010-26 eLIBRA Wrench 2.5mm Hex Female

5 60-9201 20-8012-010-22 Wrench T-Handle T-20

6 61-9064 20-8012-010-21 eLIBRA TIB INS SU ADPT SML 5mm

7 61-9063 20-8012-010-19 eLIBRA TIB INS SU ADPT LRG 5mm

8 61-8749-05 20-8012-010-18 eLIBRA UNIV TIB INSRT LRG 13mm

9 61-8749-04 20-8012-010-17 eLIBRA UNIV TIB INSRT LRG 12mm

10 61-8749-03 20-8012-010-16 eLIBRA UNIV TIB INSRT LRG 11mm

11 61-8749-02 20-8012-010-15 eLIBRA UNIV TIB INSERT LRG10mm

12 61-8749-01 20-8012-010-14 eLIBRA UNIV TIB INSERT LRG 9mm

13 61-8748-05 20-8012-010-13 eLIBRA UNIV TIB INSERT SML13mm

14 61-8748-04 20-8012-010-12 eLIBRA UNIV TIB INSERT SML12mm

15 61-8748-03 20-8012-010-11 eLIBRA UNIV TIB INSERT SML11mm

16 61-8748-02 20-8012-010-10 eLIBRA UNIV TIB INSERT SML10mm

17 61-8748-01 20-8012-010-09 eLIBRA UNIV TIB INSERT SML 9mm

18 60-9218 20-8012-010-08 LIBRA STER Tray Base With Tag

19 60-9215 20-8012-010-27 LIBRA Sterile Tray Lid

20 60-9203 20-8012-010-07 LIBRA Introducer

21 60-9020 20-8012-030-05 LIBRA ADPT Block ZNK

22 60-4824 20-8012-030-04 LIBRA FEM Component ZNK LRG LT

23 60-4823 20-8012-030-03 LIBRA FEM Component ZNK LRG RT

24 60-4822 20-8012-030-02 LIBRA FEM Component ZNK SML LT

25 60-4821 20-8012-030-01 LIBRA FEM Component ZNK SML RT

26 60-9058 20-8012-030-06 LIBRA ADPT Block ZNK-F

Page 21: Orthopaedic Devices | Hip | Knee | Shoulder - …...total knee procedures. Symptoms include, but are not limited to, lateral knee pain, instability while ascending or descend-ing stairs,

21

Zimmer® CAS eLIBRA® Dynamic Knee Balancing System (DKBS)Surgical Technique

Tibial Insert Trial Kit for Zimmer NexGen Systems

Tibial Insert Trial Kit with Spacer Paddles for Zimmer NexGen Systems

No. Manuf. No. Zimmer Prod. No. Description

CAS101 61-9652 KT-8012-020-01 eLIBRA TIB INS TRI Set ZNG

1 61-8541-01 / 61-8974-01 20-8012-020-02 eLIBRA TIB INS TRI ZNG 3-4 8mm

2 61-8541-02 / 61-8974-02 20-8012-020-03 eLIBRA TIB INS TRI ZNG3-4 10mm

3 61-8541-03 / 61-8974-03 20-8012-020-04 eLIBRA TIB INS TRI ZNG3-4 12mm

4 61-8541-04 / 61-8974-04 20-8012-020-05 eLIBRA TIB INS TRI ZNG3-4 14mm

5 61-8541-05 / 61-8974-05 20-8012-020-06 eLIBRA TIB INS TRI ZNG3-4 17mm

6 61-8542-01 / 61-8975-01 20-8012-020-07 eLIBRA TIB INS TRI ZNG 5-6 8mm

7 61-8542-02 / 61-8975-02 20-8012-020-08 eLIBRA TIB INS TRI ZNG5-6 10mm

8 61-8542-03 / 61-8975-03 20-8012-020-09 eLIBRA TIB INS TRI ZNG5-6 12mm

9 61-8543-04 / 61-8975-04 20-8012-020-10 eLIBRA TIB INS TRI ZNG5-6 14mm

10 61-8543-05 / 61-8975-05 20-8012-020-11 eLIBRA TIB INS TRI ZNG5-6 17mm

11 61-8543-01 / 61-8976-01 20-8012-020-12 eLIBRA TIB INS TRI ZNG7-10 8mm

12 61-8543-02 / 61-8976-02 20-8012-020-13 eLIBRA TIBINS TRI ZNG7-10 10mm

13 61-8543-03 / 61-8976-03 20-8012-020-14 eLIBRA TIBINS TRI ZNG7-10 12mm

14 61-8543-04 / 61-8976-04 20-8012-020-15 eLIBRA TIBINS TRI ZNG7-10 14mm

15 61-8543-05 / 61-8976-05 20-8012-020-16 eLIBRA TIBINS TRI ZNG7-10 17mm

16 300-1754 20-8012-020-17 Custom INS Tray ZNG

No. Old Prod. No. New Prod. No. Description

CAS104 61-9665 KT-8012-020-02 eLIBRA TIB INS TRI ZNG Spacer Paddles

1 61-8541-01/61-8974-01 20-8012-020-02 eLIBRA TIB INS TRI ZNG 3-4 8mm

2 61-8541-02/61-8974-02 20-8012-020-03 eLIBRA TIB INS TRI ZNG3-4 10mm

3 61-8541-03/61-8974-03 20-8012-020-04 eLIBRA TIB INS TRI ZNG3-4 12mm

4 61-8541-04/61-8974-04 20-8012-020-05 eLIBRA TIB INS TRI ZNG3-4 14mm

5 61-8541-05/61-8974-05 20-8012-020-06 eLIBRA TIB INS TRI ZNG3-4 17mm

6 61-8542-01/61-8975-01 20-8012-020-07 eLIBRA TIB INS TRI ZNG 5-6 8mm

7 61-8542-02/61-8975-02 20-8012-020-08 eLIBRA TIB INS TRI ZNG5-6 10mm

8 61-8542-03/61-8975-03 20-8012-020-09 eLIBRA TIB INS TRI ZNG5-6 12mm

9 61-8542-04/61-8975-04 20-8012-020-10 eLIBRA TIB INS TRI ZNG5-6 14mm

10 61-8542-05/61-8975-05 20-8012-020-11 eLIBRA TIB INS TRI ZNG5-6 17mm

11 61-8543-01/61-8976-01 20-8012-020-12 eLIBRA TIB INS TRI ZNG7-10 8mm

12 61-8543-02/61-8976-02 20-8012-020-13 eLIBRA TIBINS TRI ZNG7-10 10mm

13 61-8543-03/61-8976-03 20-8012-020-14 eLIBRA TIBINS TRI ZNG7-10 12mm

14 61-8543-04/61-8976-04 20-8012-020-15 eLIBRA TIBINS TRI ZNG7-10 14mm

15 61-8543-05/61-8976-05 20-8012-020-16 eLIBRA TIBINS TRI ZNG7-10 17mm

Page 22: Orthopaedic Devices | Hip | Knee | Shoulder - …...total knee procedures. Symptoms include, but are not limited to, lateral knee pain, instability while ascending or descend-ing stairs,

Zimmer® CAS eLIBRA® Dynamic Knee Balancing System (DKBS)Surgical Technique

22

Tibial Insert Trial Kit for Zimmer Natural-Knee Systems

No. Manuf. No. Zimmer Prod. No. Description

CAS103 61-9648 KT-8012-040-01 eLIBRA TIB INS TRI Set ZNK

1 61-8723-01 20-8012-040-01 eLIBRA TIBINS TR ZNK1&2LT 7mm

2 61-8723-02 20-8012-040-02 eLIBRA TIBINS TR ZNK1&2LT 9mm

3 61-8723-03 20-8012-040-03 eLIBRA TIBINS TR ZNK1&2LT 11mm

4 61-8723-04 20-8012-040-04 eLIBRA TIBINS TR ZNK1&2LT 13mm

5 61-8723-05 20-8012-040-05 eLIBRA TIBINS TR ZNK1&2LT 16mm

6 61-8724-01 20-8012-040-06 eLIBRA TIBINS TR ZNK1&2RT 7mm

7 61-8724-02 20-8012-040-07 eLIBRA TIBINS TR ZNK1&2RT 9mm

8 61-8724-03 20-8012-040-08 eLIBRA TIBINS TR ZNK1&2RT 11mm

9 61-8724-04 20-8012-040-09 eLIBRA TIBINS T ZNK 1&2RT 13mm

10 61-8724-05 20-8012-040-10 eLIBRA TIBINS T ZNK 1&2RT 16mm

11 61-8725-01 20-8012-040-11 eLIBRA TIBINS TZNK3,4&5 LT 7mm

12 61-8725-02 20-8012-040-12 eLIBRA TIBINS TZNK3,4&5 LT 9mm

13 61-8725-03 20-8012-040-13 eLIBRA TIBNS TZNK3,4&5 LT 11mm

14 61-8725-04 20-8012-040-14 eLIBRA TIBNS TZNK3,4&5 LT 13mm

15 61-8725-05 20-8012-040-15 eLIBRA TIBNS TZNK3,4&5 LT 16mm

16 61-8726-01 20-8012-040-16 eLIBRA TIBNS T ZNK3,4&5 RT 7mm

17 61-8726-02 20-8012-040-17 eLIBRA TIBNS T ZNK3,4&5 RT 9mm

18 61-8726-03 20-8012-040-18 eLIBRA TIBNS TZNK3,4&5 RT 11mm

19 61-8726-04 20-8012-040-19 eLIBRA TIBNS TZNK3,4&5 RT 13mm

20 61-8726-05 20-8012-040-20 eLIBRA TIBNS TZNK3,4&5 RT 16mm

21 300-1799 20-8012-040-21 Custom INS Tray ZNK

No. Old Prod. No. New Prod. No. Description

16 300-1820 20-8012-020-26 Custom INS Tray ZNG Spacer Paddles

17 61-8980-01 20-8012-020-18 eLIBRA SPACE PADDLE ZNG SM 8mm

18 61-8980-02 20-8012-020-19 eLIBRA SPACE PADDL ZNG SM 10mm

19 61-8980-03 20-8012-020-20 eLIBRA SPACE PADDL ZNG SM 12mm

20 61-8980-04 20-8012-020-21 eLIBRA SPACE PADDL ZNG SM 14mm

21 61-8981-01 20-8012-020-22 eLIBRA SPACE PADDLE ZNG LG 8mm

22 61-8981-02 20-8012-020-23 eLIBRA SPACE PADDL ZNG LG 10mm

23 61-8981-03 20-8012-020-24 eLIBRA SPACE PADDL ZNG LG 12mm

24 61-8981-04 20-8012-020-25 eLIBRA SPACE PADDL ZNG LG 14mm

Tibial Insert Trial Kit with Spacer Paddles for Zimmer NexGen Systems (continued)

Page 23: Orthopaedic Devices | Hip | Knee | Shoulder - …...total knee procedures. Symptoms include, but are not limited to, lateral knee pain, instability while ascending or descend-ing stairs,

23

Zimmer® CAS eLIBRA® Dynamic Knee Balancing System (DKBS)Surgical Technique

ManufacturerSynvasive Technology, Inc. 8690 Technology Way, Inc. Reno, NV 89521 USA

Tel: (916) 939-3913 Fax: (916) 939-3919

A subsidiary of Zimmer, Inc.

EC RepresentativeCEpartner4U Esdoornlaan 13 3951DB Maarn The Netherlands

Page 24: Orthopaedic Devices | Hip | Knee | Shoulder - …...total knee procedures. Symptoms include, but are not limited to, lateral knee pain, instability while ascending or descend-ing stairs,

97-7100-045-00 XML Printed in USA ©2012 Zimmer, Inc.

This documentation is intended exclusively for physicians and is not intended for laypersons.Information on the products and procedures contained in this document is of a general nature and does not represent and does not constitute medical advice or recommendations. Because this information does not purport to constitute any diagnostic or therapeutic statement with regard to any individual medical case, each patient must be examined and advised individually, and this document does not replace the need for such examination and/or advice in whole or in part. Please refer to the package inserts for important product information, including, but not limited to, contraindications, warnings, precautions, and adverse effects.

The CE mark is only valid if it is also printed on the product label.

5

Contact your Zimmer representative or visit us at www.zimmer.com