Surgical Technique

PROMOS™ STANDARD Surgical Technique

Table of ContentsIntroduction ....................................................................................................... 1Indications ......................................................................................................... 2Contraindications .............................................................................................. 2Preoperative planning ....................................................................................... 3Patient positioning ............................................................................................ 4Surgical Technique ............................................................................................ 5Revision surgery and disconnection of the components .................................... 29Recommendations for rehabilitation ................................................................. 33Implants ............................................................................................................. 35Instrument sets .................................................................................................. 37

Nota Bene

The technique description herein is made available to the healthcare professional to illustrate the authors’ suggested treatment for the uncomplicated procedure. In the final analysis, the preferred treatment is that which addresses the needs of the patient.

1

The modular versatility of the PROMOS™ STANDARD Modular Shoulder System creates a specialized implant to match each patient’s anatomical requirements, and the PROMOS non-cemented stem design is based on the proven philosophy of diaphyseal anchorage. The biconical stem allows high primary stability and the rectangular cross-section ensures rotational stability.

Assembly of the modular components is performed in situ and step by step, facilitating anatomical adaptability. The system also offers ability to assemble the implants on the back-table.

PROMOS STANDARD components:

• Diaphyseal anchoring stem

• Body for adjustment of prosthesis height and version

• Inclination set for medial offset and adjustment of inclination and version

• Eccentric humeral head for anatomical resection coverage

• Cemented PE-glenoid to cover the glenoid and for a defined translation of the head in the joint

The defined mismatch between the glenoid and humeral head recreates normal kinematics by permitting rotational and translational movement of the humeral head.

There is complete compatibility between all the modular humeral components.

For controlled and successful implantation of the PROMOS STANDARD the instructions that follow should be read before using the system. Especially the correct indication, soft-tissue management and anatomical resection taking osteophytes into consideration, must be carefully followed.

The PROMOS Modular Shoulder System uses the same distal shaft components for the PROMOS STANDARD prosthesis as for the PROMOS REVERSE prosthesis. The proximal components for both systems are interchangeable with the PROMOS stems, allowing the user to easily convert between systems for failed cases or further developing cuff tear arthropathy in standard cases.

Introduction

2

The PROMOS™ Modular Shoulder System is a hemi or total shoulder arthroplasty system intended for restoration of shoulder motion and elimination of pain.

Indications The therapeutic goals of implanting an anatomical total shoulder prosthesis are to reduce

pain and/or bring about a functional improvement of the shoulder. Indications include:

• Primary, degenerative and inflammatory arthritis

• Secondary degenerative arthritis following previous trauma

• Avascular necrosis of the humeral head

• Complex fractures of the proximal humerus

• Failure after implantation of a shoulder hemiarthroplasty or a total shoulder arthroplasty.

Contraindications• Acute or chronic infections, local or systemic

• Neuropathic shoulder arthropathy

• Serious muscular, neurologic or vascular disorders of the shoulder joint Risk factors (relative contraindications)

• Distorted medullary cavity, ie juvenile rheumatoid arthritis

• Advanced osteoporosis

• Metabolic bone disorders influencing the formation of new bone

• Extreme loading (work, sport)

3

Preoperative planning

Utilizing radiographic templates of the implants for preoperative planning can expedite implant selection during surgery.

The radiographic templates preoperatively estimate the sizes of the humeral head, humeral stem and glenoid. A key product benefit of the PROMOS™ Modular Shoulder System is that the surgeon intraoperatively selects the most appropriate body and inclination set sizes to precisely position the humeral head to most closely approximate the patient’s natural anatomy.

Literature numbers for preoperative templates 71281470: PROMOS STANDARD Template includes humeral

head, stem with proximal body and glenoid components.

Identify the anatomical neck Mark the position of the anatomic neck on the radiograph to designate the humeral resection

and establish the reference level from which to anatomically position the humeral head.

Estimate the size of the humeral head prosthesis Overlay the resection line labeled on the humeral head template upon the resection line

marked on the patient’s radiograph. Select the size of humeral head template most closely matching the diameter of the patient’s humeral head.

Estimate the size of the stem Place a medium (35mm height) body template 2–3mm below the resection level to serve as

a spacer. Position the stem template to engage the body template selecting the stem template size that fills the intramedullary canal just below the body.

Estimate the size of the glenoid Determine the size (1–4) of the glenoid implant using the glenoid templates.

Resektion

4

The patient is placed in a semi-sitting (beach chair) position, inclined approximately 30° or more. The patient should be positioned on the operating table as far as possible to the side being operated on. The shoulder and arm should come to rest beyond the edge of the table in order that the arm can be freely extended, adducted slightly, and subjected to external rotation.

Especially in the case of obese patients, it is important to ensure good positioning with appropriate freedom of arm movement. Adequate exposure of the dislocated proximal humerus without torsional or flexural forces being exerted on the humerus by the edge of the table is essential for accurate, safe implantation of shoulder prosthesis. The sterile drape is placed so that the arm can be moved freely during the operation.Optionally, an arm holder can be used.

Patient positioning

5

Approach to the glenohumeral joint

A standardized deltopectoral approach is recommended. This approach calls for anatomically accurate and stable reinsertion of the muscle-tendon units (subscapularis tendon and/or the deltoid muscle).

The deltopectoral interval is opened medial to the cephalic vein to preserve venous discharge from the deltoid muscle. The anterior humeral circumflex vessels are exposed and ligated.

The anatomical landmarks (rotator interval, bicipital groove, lesser and greater tuberosities) allow precise orientation in relation to the humeral head. The subscapularis tendon is transected 1 cm medial of the insertion on the lesser tuberosity together with the articular capsule and subsequently reinserted laterally, with a direct side-to-side, preferably transosseous suture of the tendon ends. Lengthening of the subscapularis is not needed if a complete release is performed. This step is crucial for adequate postoperative range of motion.

We recommend circumferential mobilization of the subscapularis tendon. This is achieved by incision of the rotator interval including transection of the coracohumeral ligament at the base of the coracoid. Then the capsule is sharply released from the anterior glenoid and adhesions are resected, including the more medial tendon muscle unit from the anterior scapular neck. By means of this circumferential release, the tendon-muscle unit of the subscapularis muscle becomes functional again with normal excursion. This step is crucial for adequate postoperative range of motion.

A continuation of the capsulotomy with release of the capsular contractures, especially inferiorly, facilitates the subsequently necessary dislocation of the humeral head in order to expose the humerus for humeral head preparation and anatomical resection. Attention should be paid to the location of the n. axillaris via palpation or visualization to ensure that the nerve remains protected. After humeral head resection, a capsulotomy is completed in a later step, the aim being circumferential arthrolysis.

Surgical Technique

6

Resection of the humeral head

The average angle of inclination is approximately 135° for the humerus. Humeral version varies between 5° anteversion and 60° retroversion (25–30° retroversion on average). The anatomical neck defines these individual angles. Bringing the PROMOS™ head parallel to the resection is an important part of restoring the anatomy. With the adjustability of the inclination set and the body, these angles can be infinitely adjusted.

The resection level (anatomical neck) corresponds to the tendon insertions of the subscapularis and the supraspinatus. Viewed dorsally, the cartilage-free zone from 6–8mm medially of the tendon insertion of the infraspinatus and the teres minor must be taken into account (i.e. preserve the bare area posteriorly).

Exposure of the humeral head is performed with cautious external rotation while the arm is held in the adducted and extended position. This maneuver is only possible if the patient is positioned correctly. The exposure is facilitated by the described release of capsular contractures by means of an extensive semicircumferential capsulotomy. As a result, complete external rotation is made possible with corresponding humeral head exposure without any flexural or torsional forces acting on the humeral stem. The patient’s hand should point towards the head of the OR table.

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Completely remove the humeral osteophytes circumferentially in order to expose the anatomical neck of the humerus. The capsular reflection defines the anatomical neck ventrally, inferiorly and superiorly, and thus defines the resection plane.

Note

The accurate exposure of the anatomical neck, and hence the resection plane, is a prerequisite for accurate resection of the humeral head and subsequent anatomical shoulder reconstruction. Anatomical resection of the humeral head will retain the patient’s native humeral head inclination and version.

The humeral head is resected along the level of the anatomical neck using an oscillating saw.

Note

In the case of secondary arthrosis, (e.g. dislocated humeral head, multi-fragment fractures with persistent malalignments of the tuberosity), resection of the humeral head is performed to also allow substantial room for maneuvering. Taking the condition of the soft tissues into consideration, the prosthesis can thus be adapted to suit the changed insertion areas of the rotator cuff and also the incorrectly healed tuberosity. As a result, additional osteotomies of the tuberosity can be avoided.

The size of the prosthesis head can be determined by superimposing the trial head over the resected humeral head. If no head fits perfectly, choose the smaller option.

Note

The radius of the selected humeral head component later determines the radius of curvature of the glenoid component.

8

Preparation of the glenoid and implantation of the glenoid component

After humeral head resection, the arm is returned to the neutral position. In order to expose the glenoid, the humerus is retracted postero-inferiorly using a humeral head retractor which is applied to the posterior glenoid neck. In addition, retractors are employed around the glenoid, usually with one anteriorly on the scapular neck and one superiorly. The capsulotomy is completed dorsally in order that the result is circumferential arthrolysis with complete soft-tissue release. This is the only way to completely expose the glenoid, which is a prerequisite for proper implantation of the glenoid component.

The prerequisite for accurate anatomical implantation of the glenoid component is identification of any arthrosis-induced bony glenoid change in each specific case. Preoperatively the shape and version of the glenoid can be obtained from axial X-Ray images and a CT scan or MRI if necessary. Glenoid retroversion must be recognized in order to correct glenoid version, if needed.

Next, the glenoid is debrided down to the osseous glenoid by removing any remaining parts of the anterior lip osteophytes and any residual cartilage.

The final determination of glenoid implant size is performed intraoperatively with the aid of a transparent glenoid template (sizes 1–4). The template is positioned using the holder in such a way that the surface of the glenoid fossa is completely covered by the relevant glenoid template. When trying to decide between two sizes, the smaller size should be selected.

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Humeral head radius Glenoid size/radius

R19

R20

1–23

2–23

3–23

4–23

R21

R22

R23

1–26

2–26

3–26

4–26

R24

R25

R26

1–29

2–29

3–29

4–29

R27

R28

2–32

3–32

4–32

The radius of the selected humeral head component determines the radius of the glenoid component and is only determined during the operation, as described.

There are four radii and four glenoid sizes available. The correct glenoid radius depends on the radius of the selected humeral head. The possible combinations of glenoid sizes and glenoid radii with the corresponding humeral head can be seen by referring to the compatibility chart located in the instrument set.

In case of doubt, if the humeral head size could not be precisely determined, the glenoid with the larger radius should be selected.

Ideally, there should be a 3–5mm mismatch between the humeral head radius and the glenoid radius. Having a smaller humeral head radius in relation to the glenoid radius enables the physiologic translation of the glenohumeral joint.

The 3mm guide wire is passed through the central hole in the correct glenoid template. Consequently, any off-center glenoid wear should be corrected in order to direct the guide wire perpendicular to the required corrected ver-sion of the glenoid implant. Select the direction for the wire with the index finger on the ventral glenoid neck. The orientation of the wire can be anticipated in the direction of the scapular pillar for correct placement of the glenoid component.

After placing the guide wire, the glenoid template is removed and the correct position of the guide wire is checked again.

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The glenoid fossa is reamed gradually, starting with the smallest segmented reamer (Ø30mm), until the size of the selected glenoid implant has been reached. The reamer is applied over the guide wire and placed onto the glenoid.The drive shaft is then brought over the guide wire and attached to the reamer.

Matching of the glenoid components with the reamers:

Starting: Reamer 30mmGlenoid 1+2: Reamer 36mmGlenoid 3+4: Reamer 42mm

Caution: In order to prevent glenoid fractures especially in osteoporotic or sclerotic situations, the reamer should be started before applying axial forces to the drive shaft. In doubt, hand reaming is possible with the awl handle.

Ensure clearance for the reamer with the retractor.

Protecting the axillary nerve, the glenoid fossa is reamed carefully, preserving the guide wire direction with each pass reaming step, only into the subchondral bone.

The central drill hole is made using the cannulated 6.5mm drill over the guide wire. The drill is driven forward up to the stop and then the drill and guide wire are removed.

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Inserting the centering pegs

Push the tube over the rod in the correct direction (arrow is pointing to the tip).

Load the inserter with the needed peg (first 6.5mm, then two 5.5mm pegs) directly from the instrument tray. Tilt the inserter slightly (1) then push softly over and get in axis to the peg until it clicks (2). The inserter is then removed together with the peg (3).

Insert a peg through the guide into the predrilled hole and push the knob of the metal rod to release the peg. (4)

Note

The centering peg inserter has been designed to require only manual manipulation. This instrument is not intended to experience either hammering blows or impulse forces from other instrumentation.

The glenoid drill guide of the appropriate glenoid size is mounted on the drill guide holder so that the handle is ventral and the wider part of the drill guide with the two holes is caudal.

The drill guide is now positioned on the prepared glenoid surface and secured in the central drilled anchorage hole with the 6.5mm centering peg using the inserter. Rotation of the drill guide around the centering peg allows alignment of the glenoid drill guide on the longitudinal axis of the glenoid until the required position has been reached.

Note

Glenoid sizes 1 and 2 have an identical peg pattern, while glenoid sizes 3 and 4 share a peg pattern. After drilling the peg holes it is not possible to switch between sizes 1, 2 to sizes 3, 4.

The spikes on the backside of the drill guide are impacted onto the glenoid fossa using the impactor for the monoblock stem (from humeral trials tray) on the central peg.

12

Drill the peripheral glenoid anchorage holes, with the 5.5mm straight drill, up to the hard stop.

Introduce a 5.5mm centering peg, using the inserter, for stabilization of the glenoid drill guide after each drilling step. The drill guide is stabilized peripherally using at least two centering pegs.

Optionally, a flexible shaft and 5.5mm drill bits are available.

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Fig. a

Fig. b

Before implantation of the definitive glenoid component, the transparent trial glenoid is inserted to check glenoid reaming, peg anchorage holes and the size of the preselected glenoid implant.

For the placement of the trial glenoid, the glenoid holder and the glenoid holding block (left and right side) are used, as shown in Figure a.

For removal, the trial glenoid extractor is used, as shown in Figure b.

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Clear exposure of the glenoid with drying of the anchorage holes is the prerequisite for correct cementing. Only the glenoid pegs should be cemented, not the entire posterior surface of the glenoid. Follow the instructions of the cement supplier for preparation of the cement. The introduction of cement into the 4 peg anchorage holes is performed preferably with a cement syringe.

The definitive glenoid component is placed in the glenoid holding block. The glenoid holder is positioned in the cavities around the glenoid component and fixed in place (Figure c).

After introduction and impaction of the glenoid component using the glenoid holder and the glenoid impactor, any excess cement is removed, and pressure on the glenoid is maintained until the cement has hardened (Figure d).

When it has hardened, the position and stability of the implant is checked.

Fig. d

Fig. c

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Preparation of the humerus – opening the humeral canal

The proximal humerus is exposed again by cautious external rotation while the arm is kept in an adducted, extended position.

Fit the handle with the quick adapter onto the awl.

Insert the awl turning left and right into the center of the medullary canal.

Once the optimal depth has been reached, the rasp may be introduced.

Starting with the smallest stem rasp (02), the humeral stem is broached using the rasp adaptor.

Connect the rasp adaptor to the rasp pushing the hook down.

Secure the hook pushing the lock forward.

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The depth markings on the stem rasp with the steep angle show the available height range of the standard body (30, 35, 40), the shallow angle (155°) shows the reverse body heights (5, 10, 15).

Introduction of the stem rasp is ideally performed in axis to the humeral shaft, which was already determined with the awl, and orthogonal to the resected surface (along the head center line). Although the plane of the resected surface will determine head retroversion, the rotatable standard body and inclination set will allow for additional fine tuning.

Note

Bear in mind the osseous shape of the proximal humerus, especially in the case of secondary arthrosis with posttraumatic malalignment. The humeral version is already determined by the humeral head resection, along the anatomical neck.

The humerus is rasped step-by-step. Care must be taken to ensure that during impaction and removal of the rasp, no torsional or flexural forces act on the humerus. In particular, torsional forces due to holding of the arm must be avoided to minimize the risk of a humeral shaft fracture in patients with poor bone quality.

The starting stem rasps should be introduced into the humerus over the third mark until the last rasp.

Insert the last stem rasp until there is good contact between the rasp and the diaphyseal cortex. The center mark corresponds to the middle height body mounted on the corresponding stem. Introduction of the rasp to the upper or lower line can be compensated by using the larger or smaller body.

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Half size stems

A “half-size” stem (sizes: 0, 1.5, 2.5, 3.5) has to be considered if contact with the next size rasp can not be reached to the first mark.

A half-size stem with small body approximately corresponds with the smaller stem with a tall body.

Note

For very small patients the 02 monoblock stems are available where the body is incorporated into the stem. The stems offer a choice of three heights in 5mm steps.

To check the humeral shaft preparation the trial stem is brought into the prepared medullary canal.

Connect the trial stem with the inserter and the T-Handle and secure it with the holding screw.

The steep depth markings on the inserter show the three available sizes of the PROMOS™ STANDARD bodies.

Check the correct fit of the trial stem in the medullary canal of the trial stem and height for the body.

It is mandatory to always check the depth with the trial stem first to ensure a proper diaphyseal fixation of the stem.

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Note

If the inserter passes the third mark, the next size rasp has to be taken to prepare a correct implant seating. In rare anatomical cases the rasp catches proximally prior to its distal fixation.

In some posttraumatic cases sclerotic bone removal can be performed medially with the 02 rasp.

Attach the appropriate size of the humeral stem component to the inserter.

Note

The steep depth markings on the inserter show the three available sizes of the PROMOS™ STANDARD bodies.

The stem is seated carefully with hammer blows until the implantation height determined with the trial stem, has been reached. The axial orientation previously determined using the rasp must be observed.

Then the inserter is carefully removed from the stem by loosening the holding screw.

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Trial body and inclination set

Optimal adaption of the prosthesis to the bony anatomy of the humerus can be achieved with the appropriate selection of the body, inclination set and eccentric humeral head. You can put different trials on implants until you are satisfied with the resulting construct.

The combination of body height and inclination set lengths influences the position of the taper relative to the resection plane. Make sure that the chosen body is not higher than the resection plane. Correct placement of the inclination set is in the lower half of the resection plane in normal anatomical situations. Make sure that the combination of body height, inclination set length and eccentric humeral head provides optimal coverage of the osteotomy.

Choose the trial body according to the marking on the stem inserter. Place the trial body on the taper of the inserted implant stem. The middle of the trial body – marked through the threaded hole the inclination set screws into – should end up approximately 2-3mm below the resection plane.

Note

The face of the body does not have to be parallel to the resection plane. The appropriate combination of inclination set orientation and eccentric humeral head will determine in the most anatomical positioning.

Remove cancellous bone to rotate the body if the correct retroversion is not achieved after rasping.

The proximal body can be rotated 360° and locked in place. This variability makes it possible to adapt the implant in situ to the corresponding misalignment.

20

Attach the T25 insert bit into the quick coupling of the modular screwdriver.

Tighten the trial body to the stem with the screwdriver, the body can be held with the body holding fork.

Note

The modular T-Handle should be used anytime you need to loosen the screw connections of the PROMOS™ Modular Shoulder System and also when tightening or loosening trial components.

Loosening screws with the torque wrench will damage the torque mechanism. Always use the torque screw driver to tighten implant screws.

02 size Stems

After rasping check with the 02 trial stems the correct height to the resection plane.

You can pull out the trial stem using the screw of the body extractor. The 02 implant stem can be removed the same way.

The 02 implant stem is pressed down and seated with hammer blows on the impactor for monoblock stems.

21

Humeral head offset can be adjusted in 2mm increments by selecting the desired length of inclination set. Make sure that the eccentric head has a clearance of 1-2mm over the resection plane, so that the head taper can lock properly. Placing the bottom of the inclination set parallel to the resection plane ensures correct inclination and retroversion.

Screw the trial inclination set into the body using the modular screwdriver and the T25 insert.

Note

When screws are inserted they should be turned initially half a turn counter-clockwise before actually being tightened to ensure that the thread is properly aligned with the mating threads.

Place the sleeve alignment disc on the taper of the inclination set and release the screw again.

Use the disc to lift the upper portion of the inclination set slightly and place it parallel to the resection plane by turning and tilting it.

If the correct positioning is achieved, slightly tighten the screw and take the disc off.

22

The trial head is mounted on the trial inclination set and rotated until optimum coverage of the osteotomy is achieved. When in doubt between two head sizes, choose the smaller size for better translation of the joint.

Note

The transparent trial heads correspond to the implant heads with an eccentricity from +2mm to +7mm that increases with head size. The blue trial heads have a fixed eccentricity of +4mm for all sizes.

If the eccentric position of the head does not permit adequate coverage of the osteotomy, it can be corrected with a different combination of body and inclination set.

In cases where the head does not fit exactly, the upper dorsal portion should have the best coverage, overlapping bone in the inferior portion can be removed.

To ensure complete connection between the humeral head and the inclination set taper, use the resection stylus to determine that there is no contact between the humeral head and the resected surface.

Trial reduction and verification of stability/function

The joint is reduced with the stable trial prosthesis in order to check shoulder function and articular stability. Relaxed, the humeral head component should be well centered in the glenoid with arm in neutral rotation. It should be possible to subluxate the humeral head in relation to the glenoid by approximately half a head’s width posteriorly.

The shoulder joint is dislocated carefully with humeral external rotation, trial components are removed for implantation of the definitive prosthesis components.

23

Pull off the trial head. Unscrew the trial inclination set and then the trial body.Engage the standard extractor adapter (part I/II) into the trial body. Screw the extractor screw (part II/II) into the extractor adapter and remove the trial body.

Note

Prior to implantation of the definitive body, transosseous, non-resorbable sutures (No. 2 or larger) are placed through the lesser tuberosity. This facilitates subsequent repair of the subscapularis tendon.

The taper of the stem has to be cleaned. Then the body selected is mounted on the taper in the correct position and pushed slightly down on the stem.

The body is pressed onto the distal stem with the clamp for in situ assembly (1).

For in situ assembly, the two-part connection screw (2) is introduced into the assembly clamp, and the adaptor (3) corresponding to the selected body height (30, 35, 40) is mounted on the assembly clamp.

The assembly clamp is placed onto the body and the connection screw is tightened to the stem. The clamp handles will open as the screw is tightened to the stem. When the clamp handles are squeezed together, the body is fixed to the stem without changing the position of the stem. Then the connection screw is tightened again and the clamp handles are pressed together. This process should be performed a total of three times.

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The force applied is sufficient to achieve a stable joint between the body and the stem.

The clamp is now released and removed.

Note

This is also the technique for backtable assembly.

The connection between the body and the stem is secured with the screw included. The screw is tightened using the torque screwdriver, the body can be held with the body holding fork.

Note

Verify the function of the torque screwdriver by checking if the torque indicator rests at the “Neutral” mark without torque applied. Do not overtighten or apply other forces to the torque screwdriver as this can cause damage.

Note

The PROMOS™ system is designed for in situ assembly with trial parts and implants until reconstruction of the anatomy.

Optionally there is a holding block and the body holding fork for back table assembly of the components.

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Mounting the inclination setThe inclination set is comprised of the internal cone and sleeve. The internal cone screws into the implant body. The sleeve is placed over the internal cone.

Using the torque screwdriver, advance the internal cone into the standard body so that it is securely captured, but not fully tightened.

Place the primary alignment disc on the internal cone with the 0 aligned with the laser etch on the implant. Using the disc as a handle, resume advancing the internal cone until the disc is parallel to the resected humeral surface.

If parallel alignment cannot be achieved, changing the angle of the primary alignment disc will be necessary. remove and then rotate the disc to another angle between 0 and 12 and replace it on the internal cone. using the disc as a handle, continue advancing the internal cone until the disc is parallel to the resected humeral surface.

When parallel alignment is achieved, provisionally tighten the internal cone with the torque screwdriver while holding the primary alignment disc in place.

Note

The numbers 0 to 12 on the primary alignment disc just indicate increasing angles and have no specific meaning.

Inner cone

Primary alignment disc

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With the laser etched “top” facing up, place the sleeve alignment disc over the flat surface of the sleeve. Firmly press down on the disc. Confirm that the sleeve will remain in place while only the disc is held. While the sleeve remains centered in the disc, place it over the internal cone. Using the disc as a handle, rotate the sleeve until the disc is parallel to the resected humeral surface.

Once parallel, provisionally impact the sleeve using the sleeve/head impactor. The disc may then be removed.

While using the holding fork to apply counter-torque, tighten the screw with the torque screwdriver to the “implant” mark twice.

Impact the sleeve using the sleeve/head impactor.

Sleeve alignment disc Sleeve

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If necessary, an impacted inclination set can be disassembled by positioning it between the sleeve/head impactors, as shown. A light hammer blow to the upright impactor will loosen the components.

NoteAn impacted inclination set may be disassembled and re-impacted only one time before implantation.

After placing the humeral head on the inclination set, use the resection stylus to check that it doesn’t make contact with the resected surface.

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Impact the humeral head with the sleeve/head impactor with three hammer blows.

NoteAfter impaction of the head onto the trunnion of the inclination set, the fixation can be assessed manually.

Wound closure and postoperative immobilization

The prepared, non-resorbable transosseous sutures are used for the reinsertion of the subscapularis tendon or with side-to-side repair of the tendon stumps. Then the rotator interval can be closed. Be sure the interval is closed with the arm in external rotation in the adducted position to prevent a loss of rotation. An optional drain can be placed, but it is usually not needed if adequate hemostasis and good soft-tissue technique was used throughout the procedure. The wound is then closed, layer by layer, using subcutaneous and skin sutures. The sterile dressing is applied and the operative arm is immobilized in a sling.

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Gently press the head removal tool between the gap of the head and the resected surfaceof the humerus.

If the head does not disconnect, apply a light hammer blow onto the head and the taper connection will loosen.

Unscrew the inclination set with the T25 screw driver, while using the holding fork as a counter torque.

This works with the old as well as the current inclination set. If the older type inclination set is used, place the screwdriver SW 5.0mm. The actual screw takes the T25 bit.

Note

The torque screwdriver should NOT be used for unscrewing the inclination set.

Note

Remove any residual tissue out of the bone.

Loosen the fixation screw of the standard body.

Use the modular screwdriver with the T25 bit for the current body and the SW3.5mm bit for the old type standard bodies while holding the body with the body holding fork.

Press the corresponding screw remover down into the screw head and remove the fixation screw.

Note

Apply a slight hammer blow on the remover if the fit is not adequate.

Revision surgery and disconnection of the components

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Sequence of assembly of the removal device:Preassembly before surgery (orange): Place spring (A) into lever (G) afterwards base disk (B), and then secure it with the locking screw (C).

• Attach sleeve (E) to top lever (F) with a one-quarter clockwise turn (90°) while at the same time pressing down the sleeve.

• Fit the releasing clamp onto the standard body and hold it in place.

• Insert rod (D) into sleeve (E). Screw the threaded rod (D) into the implant until tight.

31

Note

When the releasing clamp is assembled, top lever (F) does not contact bottom lever (G) due to its spring-forced load.

Release the body from the stem by pressing the two levers together. Remove the body with the clamp.

Disassembling

Remove rod (D). Release sleeve (E) from the releasing clamp with a 90° counter-clockwise turn while pressing the sleeve slightly down at the same time.

Total explantation of the humeral side components

Stem extraction

After the disassembly of the body, free the well fixed stem from bony anchorage using a chisel.

Screw the extraction screw into the stem.Connect the slap hammer with fitted adapter to the extraction screw. Pull the humeral implants out of the humerus with the slap hammer.

Note

If the stem can not be extracted this way, a longitudinal osteotomy of the proximal humerus has to be performed.

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Stem extraction together with body

Remove the head and inclination set.Engage the standard extractor adapter (part I/II) into the body.

Screw the extractor screw (part II/II) into the extractor adapter and fix the adapter for slap hammer to the hammer.

Slide the slap hammer adapter over the ball head of the extractor.

To remove implants with the old PROMOS™ STANDARD body, use the extractor reverse. Pull the humeral implants out of the humerus with the slap hammer.

Remove the glenoid component and remaining cement.

Note

Glenoid components in revision cases are mostly loose and can be removed easily. For a fixed PE-glenoid use a curved osteotome to cut the glenoid face away from the pegs. To additionally remove the pegs and remaining cement use a set of high speed burrs.

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Phase 1: Assistive mobilization – first and second week after surgery

Therapy• Assisted movement in the scapular region

Note

External rotation with passive assistance up to 40° maximum (depending on intraoperative motion)

• Various soft-tissue techniques

• Scapular setting, postural correction

• Begin centering exercises in the dorsal position, taking the scapular region into account

• Oscillatory exercise instruction

• Water therapy as of Day 5

• Sling is used for protection only, not immobilization

Phase 2: Active mobilization and coordination training – third and fourth week after surgery

Therapy• Exercises in various starting positions

• Isometrics of the rotator cuff with short lever and adapted resistance, techniques as in the PNF patterns (proprioceptive neuromuscular facilitation), etc.

• Stabilisation and centering exercises to improve sensor motor function

Recommendations for rehabilitation

34

Phase 3:

Activation and ergonomics – as of the fifth week

Therapy• Increase in active and passive mobility

• Intensification of glenohumeral and scapulothoracic coordination training, including the trunk

• Improvement in stamina – combined with medical training therapy if possible

• ADL (Activity of Daily Living) training

Objectives for six weeks after surgery• Passive glenohumeral function of at least 100°

• Touching the crown of the head

• Hand behind back at least to the trochanter

Objectives for 12 weeks after surgery• Free movements (depending on preoperative condition and progress)

• Hand behind back and grip to nape of neck

35

Catalog information - Implants

Humeral head

Body

* Not part of the Set no. 7520-0676; need to be ordered separately

Cat. No. Part No. Size Qty7500-6695 42061 1–23 17500-6696 42062 1–26 17500-6697 42063 1–29 17500-6698 42064 2–23 17500-6699 42065 2–26 17500-6700 42066 2–29 17500-6716 42167 2–32 17500-6701 42067 3–23 17500-6702 42068 3–26 17500-6703 42069 3–29 17500-6717 42170 3–32 17500-6704 42070 4–23 17500-6705 42071 4–26 17500-6706 42072 4–29 17500-6718 42173 4–32 1

Cat. No. Part No. Size Qty7500-6659 42031 R19/+2 17500-6670 42032 R20/+4 17500-6681 42033 R21/+5 17500-6688 42034 R22/+6 17500-6689 42035 R23/+7 17500-6690 42036 R24/+7 17500-6691 42037 R25/+7 17500-6692 42038 R26/+7 17500-6693 42039 R27/+7 17500-6694 42040 R28/+7 17500-6707 42133 R21/+4 17500-6708 42134 R22/+4 17500-6709 42135 R23/+4 17500-6710 42136 R24/+4 17500-6711 42137 R25/+4 17500-6712 42138 R26/+4 17500-6652 42029 R27/+4 17500-6653 42030 R28/+4 1

Cemented glenoid

Cat. No. Part No. Size Qty7500-6533 42001 01 17500-6555 42009 0 17500-6537 42002 1 17500-6601 42019 1.5 17500-6538 42003 2 17500-6607 42020 2.5 17500-6539 42004 3 17500-6550 42008 3.5 17500-6541 42005 4 17501-0867 42006 5* 1

Non-cemented stem

Cat. No. Part No. Size Qty7500-6713 42160 30mm 17500-6714 42161 35mm 17500-6715 42162 40mm 1

Set No. 7520-0676

36

Cat. No. Part No. Size Qty7500-6719 42175 02/30mm 17500-6720 42176 02/35mm 17500-6721 42177 02/40mm 1

“Non-cemented monoblock stem Inclination set

Cat. No. Size Qty7504-2180 20mm 27504-2182 22mm 27504-2184 24mm 17504-2186 26mm 1

The PROMOS™ shoulder implants are packaged in a carton and three pouches.

1. The outer pouch is considered non-sterile and should be opened outside of the sterile field.

2. Peel open the outer pouch and retrieve all contents including the CHART-STIK™ labels.

3. The secondary pouch is considered a sterile barrier. Peel open the second pouch to present the contents.

Do not drop the CHART-STIK labels onto the sterile field.

4. Present the contents to the sterile field using aseptic presentation technique.

The product should not be dumped into the sterile field, but rather be transferred directly to the scrub nurse.

Instruments

The system instruments are non-sterile when delivered. Before use, they must be cleaned by the usual methods in accordance with hospital regulations and sterilized in an autoclave in accordance with the national legal regulations and recommendations. (For detailed information please refer to the leafl et Lit. No. 1363-e)

For correct settings, refer to the user instructions issued by the autoclave manufacturer.Instrument manufacturers and dealers do not accept any responsibility for the sterilization of products by the customer.

Size 5 non-cemented stem (Cat. no. 7501-0867) can be ordered along with the Set no. 7520-6033.

Cat. No. Part No. Description Qty7509-5301 24000183 Stem Rasp 5 17502-3820 24000178 Trial Humeral Stem 5 1

Set No. 7520-6033

37

Catalog information – Instrument sets

Set No. 7520-6030

Set No. 7520-6031

38

Tray 1 General Glenoid TrayTray No. 7502-3136

Cat. No. Part No. Description Qty7500-6565 420120 Glenoid Template Forceps 17500-6561 420116 Glenoid Template 1 17500-6562 420117 Glenoid Template 2 17500-6563 420118 Glenoid Template 3 17500-6564 420119 Glenoid Template 4 17500-6583 420151 Drill Guide Holder 17501-8285 2400076 Kirschner Guide

Wire 3mm3

Cat. No. Part No. Description Qty7500-6584 420152 Drill with Stop 5.5mm 17501-8286 24000077 Drive Shaft 17500-5281 24000057 Slotted Tube 17500-5275 24000051 Glenoid Reamer

Segmented, 30mm1

7500-5276 24000052 Glenoid Reamer Segmented, 36mm

1

7500-5277 24000053 Glenoid Reamer Segmented, 42mm

1

7500-5277 24000053 Glenoid Reamer Segmented, 42mm

1

39

Catalog information – Instrument sets

Tray 2 Cemented Glenoid TrayTray No. 7502-3137

Cat. No. Part No. Description Qty7500-6497 420001 Trial Glenoid 1-23 17500-6525 420002 Trial Glenoid 1-26 17500-6526 420003 Trial Glenoid 1-29 17500-6527 420004 Trial Glenoid 2-23 17500-6528 420005 Trial Glenoid 2-26 17500-6529 420006 Trial Glenoid 2-29 17500-6631 420258 Trial Glenoid 2-32 17500-6530 420007 Trial Glenoid 3-23 17500-6531 420008 Trial Glenoid 3-26 17500-6532 420009 Trial Glenoid 3-29 17500-6632 420359 Trial Glenoid 3-32 17500-6534 420010 Trial Glenoid 4-23 17500-6535 420011 Trial Glenoid 4-26 17500-6536 420012 Trial Glenoid 4-29 17500-6633 420260 Trial Glenoid 4-32 1

Cat. No. Part No. Description Qty7500-6620 420243 Glenoid Impactor 17500-6618 420241 Centering Peg Inserter 17500-6586 420154 Trial Glenoid Extractor 17500-6558 420110 Centering Peg 5.5mm 27500-6559 420111 Centering Peg 6.5mm 17500-6579 420147 Glenoid Drill Guide 1 17500-6580 420148 Glenoid Drill Guide 2 17500-6581 420149 Glenoid Drill Guide 3 17500-6582 420150 Glenoid Drill Guide 4 17500-5286 24000063 Cannulated Drill 6.5/3mm 17500-6554 420083 Drill with Stop 5.5mm 17500-3282 130490 Flexible Shaft with

Quick Couple1

7500-6567 420122 Glenoid Holder 17500-6577 420144 Glenoid Holding Block 1

40

Tray 3 General Humeral TrayTray No. 7502-3138

Cat. No. Part No. Description Qty7500-6570 420128 Rasp Adapter 27500-6578 420145 Spacer 1.3 17500-6553 420082 Awl Handle 17500-6556 420098 Awl 17500-6673 420322 Stem Rasp 01 17500-6672 420321 Stem Rasp 02 17500-6674 420323 Stem Rasp 1 17500-6675 420324 Stem Rasp 2 17500-6676 420325 Stem Rasp 3 17500-6677 420326 Stem Rasp 4 17509-5301 24000183 Stem Rasp 5* 1

Cat. No. Part No. Description Qty7500-6604 420193 Trial Humeral Stem 0 17500-6587 420156 Trial Humeral Stem 01 17500-6588 420157 Trial Humeral Stem 1 17500-6605 420194 Trial Humeral Stem 1.5 17500-6589 420158 Trial Humeral Stem 2 17500-6606 420195 Trial Humeral Stem 2.5 17500-6590 420159 Trial Humeral Stem 3 17500-6602 420191 Trial Humeral Stem 3.5 17500-6591 420160 Trial Humeral Stem 4 17502-3820 24000178 Trial Humeral Stem 5* 1

Tray 4 General Humeral Tray 2Tray No. 7502-3139

Cat. No. Part No. Description Qty7500-6593 420175 Connection Screw (2 Parts) 17500-6599 420188 Connection Screw Set 17500-6609 420205 Mounting Clamp 17500-6666 420316 Inserter 0+01 17500-6667 420317 Inserter 1+1.5 17500-6668 420318 Inserter 2+2.5 17500-6669 420319 Inserter 3+3.5 1

Cat. No. Part No. Description Qty7500-6671 420320 Inserter 4 17500-6572 420133 Holding Screw 17500-6571 420132 T-Handle 17500-6679 420328 Modular Screw Driver 17500-6643 420271 Screw Driver Stepped T25 27500-6610 420209 Torque Screwdriver 3/6NM 1

*available as part of Set no. 7520-6033

41

Catalog information – Instrument sets

Tray 5 Humeral Trials TrayTray No. 7502-1529

Cat. No. Part No. Description Qty7500-6644 420272 Body Adapter 30mm 17500-6645 420273 Body Adapter 35mm 17500-6646 420274 Body Adapter 40mm 17500-6624 420251 Trial Body 30mm 17500-6625 420252 Trial Body 35mm 17500-6626 420253 Trial Body 40mm 17500-6640 420268 Trial Monoblock Stem 02/3 17500-6641 420269 Trial Monoblock Stem 02/3 17500-6642 420270 Trial Monoblock Stem 02/4 17510-1980 75101980 Primary Alignment Disc 1

Cat. No. Part No. Description Qty7510-1981 75101981 Sleeve Alignment Disc 17500-6627 420254 Trial Inclination Set 20mm 17500-6628 420255 Trial Inclination Set 22mm 17500-6629 420256 Trial Inclination Set 24mm 17500-6630 420257 Trial Inclination Set 26mm 17500-2977 1214207 Resection Stylus 17500-6603 420192 Impactor for Monoblock 17510-1982 75101982 Holding Fork 17500-6680 420329 Backtable Holding Block 17502-3728 24000163 Screw Remover T257502-3729 24000164 Screw Remover Old Std Body SW3.5

42

Tray 6 Proximal StandardTray No. 7502-3141

Cat. No. Part No. Description Qty7510-1983 75101983 Sleeve/Head Impactor 17500-6634 420262 Trial HD R21/+4 17500-6635 420263 Trial HD R22/+4 17500-6636 420264 Trial HD R23/+4 17500-6637 420265 Trial HD R24/+4 17500-6638 420266 Trial HD R25/+4 17500-6639 420267 Trial HD R26/+4 17500-6654 420305 Trial HD R27/+4 17500-6655 420306 Trial HD R28/+4 17500-6542 420060 Trial HD R19/+2 1

Cat. No. Part No. Description Qty7500-6543 420061 Trial HD R20/+4 17500-6544 420062 Trial HD R21/+5 17500-6545 420063 Trial HD R22/+6 17500-6546 420064 Trial HD R23/+7 17500-6547 420065 Trial HD R24/+7 17500-6548 420066 Trial HD R25/+7 17500-6549 420067 Trial HD R26/+7 17500-6622 420248 Trial HD R27/+7 17500-6623 420249 Trial HD R28/+7 17500-6615 420214 Compatibility Chart 1

Tray 7 Revision TrayTray No. 7502-3142

Cat. No. Part No. Description Qty7500-7142 600181 Slap Hammer 17500-6611 420210 Screwdriver Bit SW 3.5 17500-6612 420211 Screwdriver Bit SW 5.0 17502-3134 24000158 G.S. Release Adapter 17502-3373 24000160 G.S. Screw Loosening

Adapter1

Cat. No. Part No. Description Qty7502-3135 24000159 Release Clamp (3-part) 17500-6621 420247 Slap Hammer Adapter 17500-6617 420240 Stem Extractor 17500-6647 420275 Extractor 17500-5283 24000059 Extractor Reverse 17500-6557 420109 Humeral Head Remover 1

43

Catalog information – Instrument sets

Tray 8 Stem ReverseTray No. 7502-3572

Cat. No. Part No. Description Qty7500-5272 24000048 Reverse Humeral

Reamer ø361

7500-5273 24000049 Reverse Humeral Reamer ø42

1

7500-5259 24000033 Trial Reverse Body 36/5mm 17500-5260 24000034 Trial Reverse Body 36/10mm 17500-5261 24000035 Trial Reverse Body 36/15mm 17500-5262 24000036 Trial Reverse Body 42/5mm 17500-5263 24000037 Trial Reverse Body 42/10mm 17500-5264 24000038 Trial Reverse Body 42/15mm 17500-5238 24000012 Trial Insert 36/6mm 17500-5239 24000013 Trial Insert 36/9mm 17500-5240 24000014 Trial Insert 36/12mm 17500-5241 24000015 Trial Insert 42/6mm 17500-5242 24000016 Trial Insert 42/9mm 17500-5243 24000017 Trial Insert 42/12mm 17501-8925 24000151 Reverse Orientation

Device ø361

7501-8926 24000152 Reverse Orientation Device ø42

1

7500-5266 24000040 Rev. Body Loosening Adaptor ø36

1

Cat. No. Part No. Description Qty7500-5267 24000041 Rev. Body Loosening

Adaptor ø421

7500-5284 24000061 Trial Insert Extractor 17500-5265 24000039 Reverse Body

Mounting Adaptor1

7500-5257 24000031 Stem Extension 17500-5253 24000027 Humeral Cut Block 17501-8917 24000143 Reverse Cutting Device 17501-8924 24000150 Rev. Reamer Guide

Fixation Device1

7500-5235 24000009 Reamer Guide 5mm 17500-5236 24000010 Reamer Guide 10mm 17500-5237 24000011 Reamer Guide 15mm 17500-5228 24000002 Reverse Hollow Reamer 17501-8916 24000142 Reverse Cutting

Adaptor Right1

7501-8915 24000151 Reverse Cutting Adaptor Left 17501-8918 24000144 Orientation Pins 37500-5256 24000030 Cut Block Pins 47500-5252 24000026 Sleeve to Cutting Device 17500-5278 24000054 Adapter Cut Block Pins 2

Supplemental Reverse Instrument SetSet no. 7520-6031

44

Tray 9 Glenoid ReverseTray No. 7502-3571

Cat. No. Part No. Description Qty7500-5282 24000058 Glenoid Baseplate

Impactor1

7501-8288 24000079 Drill Sleeve Ø4mm 27510-0384 24000203 Drill Ø4mm 27501-8922 24000148 Trial Glenosphere Centric 17501-8923 24000149 Trial Glenosphere Centric 17501-8912 24000138 Trial Glenosphere Eccentric 17501-8913 24000139 Trial Glenosphere Eccentric 17500-5270 24000046 Glenosphere Mounting

Adaptor1

7501-8911 24000137 Glenosphere Drill Guide 1

7500-5267 24000041 Rev. Body Loosening Adapter ø42

1

Cat. No. Part No. Description Qty7501-8909 24000135 Centric Glenosphere

Adaptor1

7501-8910 24000136 Eccentric Glenosphere Adaptor

1

7500-5245 24000019 Glenoid Central Reamer 17501-8914 24000140 Glenoid Peripheral Reamer 17501-8927 24000153 Trail Fixation Screw Inserter 17501-8908 24000134 Fixation Screw Inserter 17501-8907 24000193 Inserter Glenosphere 17500-5268 24000042 Impactor PE Insert 36mm 17500-5269 24000043 Impactor PE Insert 42mm 1

Smith & Nephew, Inc.7135 Goodlett Farms ParkwayCordova, TN 38016USA

ManufacturerSmith & Nephew Orthopaedics AGOberneuhofstrasse 10d6340 BaarSwitzerland

Telephone: 1-901-396-2121Information: 1-800-821-5700Orders and Inquiries: 1-800-238-7538

www.smith-nephew.com

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