TORNIER AFFINITI EH 2. Extended Humeral Head SURGICAL TECHNIQUE

Transcription

1 TORNIER AFFINITI EH 2 Extended Humeral Head SURGICAL TECHNIQUE

2 The AFFINITI Extended Humeral Head System was developed in collaboration with: John Brems, MD Cleveland, OH R. Sean Churchill, MD Milwaukee, WI Ed Fehringer, MD Omaha, NE Brian Holloway, MD Knoxville, TN Edwin Spencer, MD Knoxville, TN 2

3 Table of Contents: Design Rationale...4 Indications...5 Contraindications...5 Pre-Operative Planning...6 Exposure...6 Free Hand Osteotomy...8 Anterior Intramedullary Guide Lateral Intramedullary Guide Preparing the Metaphysis Humeral Head and Stem Options Selecting a Humeral Head Trial Humeral Implant Assembly Insertion of the Definitive Assembly Closure Post Operative Rehabilitation Instruments

4 Surgical Technique Design Rationale Cannulated Broaches & Size Specific Tuberosity Reamers Improves operative efficiency and surgical flow by removing guesswork and the need for freehand trimming Cannulated broach provides a fixed depth stop and the stability necessary for accurate reproducible reaming Precise fit between the underside of the humeral head implant and the prepared proximal humerus Preserves bone compared to the traditional tuberosity resection Increased Superolateral Implant Coverage Provides more exact transition between the implant and the lateral cortex Extended implant coverage potentially increases range of motion in abduction and rotation and may help reduce pain Multiple lateral articular radii help to center the humeral head during abduction and may increase range of motion. Lateral Cut Guide for Subscapularis Sparing Approach Allows surgeon to accurately resect the humeral head without taking down the subscapularis Decreases operative time Minimizes post-operative restrictions, recovery time and the need for rehabilitation 4

5 Indications The AFFINITI Total and Hemi-Shoulder System is indicated for: Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis Fracture/dislocation of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon s experience indicates that alternative methods of treatment are unsatisfactory Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component) Hemi-Shoulder replacement with the AFFINITI EH2 System, is also indicated for: Ununited humeral head fractures Avascular necrosis of the humeral head Rotator cuff tear arthropathy Note: Glenoid components are labeled for cemented use and are indicated only for use with bone cement. Humeral stems are indicated for press-fit uncemented use or for use with bone cement. Contraindications AFFINITI System Total or Hemi-Shoulder: Lack of quality bone to seat and support the implant, including that resulting from skeletal immaturity or osteoporosis Metal allergies or sensitivity Infection at or near the site of implantation Distant or systemic infection AFFINITI System Total Shoulder: Lack of sufficiently sound muscle or rotator cuff to seat and support the implant 5

6 Pre-Operative Planning Four shoulder X-rays are recommended: 1. A-P View 2. True A-P or Grashey View 3. Supraspinatus Outlet View (SOV) 4. Axillary View MRI to confirm the integrity of the rotator cuff if there is a clinical question about the cuff integrity. Exposure Position the patient in a beach chair position with the operative arm draped free. For optimal access, the patient should be positioned near the edge of the operating table such that the shoulder can be fully extended. A bump can be placed under the operative shoulder to stabilize the scapula. A delto-pectoral incision is performed. Begin at the coracoid and extend distal and lateral along the delto-pectoral groove, lateral to the axillary fold, to avoid a post-operative contracture. Once the subcutaneous tissue has been divided and superficial hemostasis has been completed, the cephalic vein is identified. Carefully develop the deltopectoral interval, using the cephalic vein and the coracoid as a guide. Retract the vein laterally with the deltoid. Release the clavipectoral fascia from the coracoid to the pectoralis insertion. With the arm abducted and slightly internally rotated, the long head of the biceps is inspected. At this point, extensive bicipital synovitis, loose bodies, or osteophytes in the bicipital groove should be removed. Finally, frequently the long head of the biceps tendon is either ruptured, dislocated, or partially torn. One must generally make a decision as to whether to keep it intact, tenotomize it, or tenodese it. Prior to proceeding with the exposure, the axillary nerve should be palpated. Begin with the surgeon s index finger below the coracoid. Sweep it slightly medially and inferiorly, deep to the coracobrachialis, following the anterior surface of the subscapularis. As the surgeon s finger sweeps along the inferior border of the subscapularis, the axillary nerve can be palpated as a sling of material, passing posteriorly around the inferior aspect of the glenohumeral joint. Prior to proceeding with the exposure, a decision needs to be made with regard to how to manage the subscapularis. The first option is to the leave the subscapularis intact and utilize the cuff deficiency for exposure. This is possible utilizing instrumentation provided in the standard AFFINITI EH2 instrument set. To utilize this approach, follow the technique described below titled, Subscapularis Sparing Approach for Cuff Tear Arthropathy. The second option is to perform a tenotomy of the subscapularis or lesser tuberosity osteotomy. To perform this approach, follow the technique described below titled, Standard Subscapularis Treatment for Cuff Tear Arthropathy. 6

7 Subscapularis Sparing Approach for Cuff Tear Arthropathy If the subscapularis is intact and one wishes to attempt to leave it as such, it may be possible to work through the superior cuff defect. Through a deltopectoral approach, the shoulder may be subluxed anterosuperiorly with the aid of a deltoid retractor. Medially, one may use Darrach or Bennett retractors to push the head away from the coracoid. With a flexible and lower insertion of the upper rolled border of the subscapularis, the exposure is easier. For the more robust and/or inflexible subscapularis cases, a Z-retractor can be placed on the articular side of the subscapularis to help retract the muscle/tendon unit and deliver the head superiorly into the cuff defect. An intramedullary alignment system allows one to attach a lateral cutting guide that facilitates lateral to medial cutting of the humeral head at the anatomic neck in a safe fashion. The fins of the cutting guide can be difficult to fit inside a robust subscapularis, and may require leaving the anterior fin on the bursal side. Medial osteophyte resection with this approach is more challenging. With large medial humeral head osteophytes, one may wish to perform a subscapularis tenotomy. With the head removed, the procedure is otherwise carried out as one would with a subscapularis tenotomy. Identify the anterior circumflex vessels along the inferior border of the subscapularis. Ligate or coagulate the artery and two veins just medial to the subscapularis tendon insertion on the humerus. The subscapularis can now be tenotomized or a lesser tuberosity osteotomy performed. For the tendon release, begin superiorly at the rotator interval and release the subscapularis tendon leaving a 1 cm stump on the lesser tuberosity for later repair, or take the tendon down sharply off of bone. Gentle external rotation of the humerus assists with developing this release. Tag the medial tendon with retention sutures to avoid medial retraction. Alternatively, the subscapularis insertion on the lesser tuberosity can be preserved by performing a lesser tuberosity osteotomy and removing a small superficial portion of the tuberosity with the subscapularis attachment. This should be tagged and retracted medially. The shoulder can now be dislocated. This is facilitated by placing a Darrach retractor within the glenohumeral joint and performing gentle adduction and external rotation of the humerus. As the humeral head is fully dislocated, the inferior capsule is released up to the posterior aspect of the humeral head. Palpation and protection of the axillary nerve during this release is necessary. Once these releases have been performed, the humeral head is fully dislocated by adduction of the arm with progressive external rotation and extension. With the humeral head dislocated, resect the humeral head, and then carefully trim the humeral osteophytes. It is recommended to use a rounger to separate the interval between the osteophytes and the cortical bone. 7

8 Humeral Head Osteotomy & Canal Reaming Two standard options are available for the humeral head osteotomy, and a third option has been added for the subscapularis sparing approach: Standard Deltopectoral Approach Option 1- Free hand cut using the flat plate cutting guide Option 2 - Anterior guided cut using the intramedullary cutting guide Subscapularis Sparing Approach Option 3 - Lateral guided cut using the intramedullary cutting guide Option 1 Flat Plate Guide Option 2 Anterior IM Guide Option 1 - Free Hand Cut and Reaming To determine the angle of resection, place the flat plate cutting guide along the anterior aspect of the arm parallel to the humeral shaft. The guide has been designed to correspond with the stem neck angle and should be positioned with the superior lateral portion resting at the junction of the articular surface and the greater tuberosity. (Figure 1) Once the guide has been properly aligned mark the neck angle with electro-cautery. Option 3 Lateral IM Guide Before cutting the humeral head, place the Crego retractor under the biceps tendon, if it is still present, and around the proximal humerus. This will help protect the biceps and rotator cuff tendons. With the Crego in place cut along the previously marked neck angle (135 ). Note: Take special care to direct the saw blade or osteotome directly towards the posterior tip of the Crego retractor. A misdirected cut has the potential to damage the rotator cuff tendons. Figure 1 8

9 Option 1- Preparing the Humeral Canal Using the awl tip on the smallest canal reamer, create a pilot hole just medial to the greater tuberosity, along the lateral articular margin, and centered in the A-P dimension. (Figure 2) Insert the canal reamer parallel to the humeral shaft to avoid varus or valgus alignment. Ream the canal under hand power, incrementally increasing the size of the reamer (i.e., 6 mm, 8 mm, 10 mm, etc.) until the reamer begins to contact the cortical wall of the humeral shaft. Figure 2 When reaming the humeral canal, each reamer should be inserted until the etch line contacts the lateral portion of the cut humerus. For standard length stems ream to the first etched line and for long stems ream to the second etched line. (Figure 3) Note: In the case of a wide humeral shaft, it is advisable to select a humeral stem size based upon the metaphysis and not the humeral canal. The primary fixation of the AFFINITI stem is derived from the metaphysis press-fit. (Continue to Preparing the Metaphysis) Figure 3 9

10 Option 2 - Anterior Intramedullary Guide Anterior Intramedullary Guide Assembly To assemble the anterior intramedullary guide follow the instructions listed below: Position the clamp body so that the text (left top or right top) matches the side of the patient that is undergoing the operation. Insert the clamp arm into the clamp body and secure with the clamp screw. (Figure 4) Figure 4 Attach the guide member to the clamp assembly and secure with the thumb screw. Next, attach the retroversion rod to the guide member. (Figure 5) Figure 5 10

11 Use of the Anterior Intramedullary Guide Using the awl tip of the smallest canal reamer, create a pilot hole just medial to the supraspinatus insertion point and centered in the A-P dimension. A Crego retractor assists in obtaining proper exposure and protects the biceps and rotator cuff tendons. Ream the canal under hand power, incrementally increasing the size of the reamer (i.e., 6 mm, 8 mm, 10 mm, etc.) until the reamer begins to contact the cortical wall of the humeral shaft. When reaming the humeral canal, each reamer should be inserted until the etch line contacts the superior cortices. For standard length stems, ream to the first etched line, and for long stems, ream to the second etched line. Figure 6 With the appropriate size canal reamer in place, attach the assembled guide to the flutes of the reamer. (Figure 6) Note: In the case of a wide humeral shaft, it is advisable to select a humeral stem size based upon the metaphysis and not the humeral canal. The primary fixation of the AFFINITI stem is derived from the metaphysis press-fit. 11

12 The guide has been designed to correspond with the stem neck angle and should be positioned with the lateral portion resting on the junction of the articular surface and supraspinatus insertion point. (Figure 7) The resection guide may also be adjusted in the anterior and posterior plane via the second thumb screw. This allows the guide to be flush against the anterior humerus prior to cutting. With the guide properly aligned, adjust the retroversion rod and tighten. As a reference, the retroversion has stops at 20, 30 and 40 degrees. Rotate the guide until the retroversion rod is aligned with the forearm. Introduce the three pins into the central holes. Detach the guide member from the clamp arm. Remove the clamp body and canal reamer. (Figure 8) Place the saw blade flat along the surface of the guide member and resect the humeral head. Figure 7 Note: Additional pin holes have been placed above and below the central pin holes. To adjust the height of the humeral head resection by 1 mm, slide the guide member off the pins and reattach the guide using the holes above the central hole to move the guide inferiorly or below the central hole to move the guide superiorly. (Continue to Preparing the Metaphysis) Figure 8 12

13 Option 3- Lateral Intramedullary Guide Lateral Intramedullary Guide Assembly To assemble the lateral intramedullary guide follow the instructions listed below: Position the clamp block so that the text top is visible. Insert the clamp arm into the clamp block and secure with the clamp screw. The clamp screw may be tightened with the trial head screwdriver from the AFFINITI humeral tray. (Figure 9) Select the appropriate size cut block and slide it into the slot of the clamp block. Secure the cut block with the thumb screw. Figure 9 Note: Placing the cut block as far superior as possible may ease attachment to the canal reamer. (Figure 10) Attach the version rod to the side of the clamp block corresponding to the operative side of the patient. Figure 10 13

14 Use of the Lateral Intramedullary Guide Using the awl tip of the smallest canal reamer, create a pilot hole just medial to the greater tuberosity along the lateral articular margin centered in the A-P dimension. Ream the canal under hand power, incrementally increasing the size of the reamer (i.e., 6 mm, 8 mm, 10 mm, etc.) until the reamer begins to contact the cortical wall of the humeral shaft. When reaming the humeral canal, each reamer should be inserted until the etch line contacts the superior cortices. For standard length stems ream to the first etched line, and for long stems, ream to the second etched line. With the appropriate size canal reamer in place, attach the assembled guide to the flutes of the reamer. (Figure 11) Note: In the case of a wide humeral shaft, it is advisable to select a humeral stem size based upon the metaphysis and not the humeral canal. The primary fixation of the AFFINITI stem is derived from the metaphysis press-fit. Figure 11 The guide has been designed to correspond with the stem neck angle and should be positioned inside the subscapularis and remaining posterior cuff with the top surface of the guide resting at the articular margin of the humeral head. (Figure 12) The resection guide may be adjusted in the medial and lateral plane via the thumb screw. This allows the guide to be flush against the lateral humerus prior to cutting. Figure 12 14

15 The retroversion rod of the cutting guide can be used as reference point, and represents 30 degrees retroversion when parallel to the forearm. To adjust the guide, simply use the T-Handle and rotate the construct to the desired version. When the desired version and height have been selected, place the cut block flush against the bone, introduce the pins into the two holes, and advance them into the humerus to secure the cut block. Detach the clamp block assembly from the cut block by unscrewing the thumb screw. (Figure 13) Figure 13 With the clamp block assembly detached, rotate the assembly away from the cut block and remove the clamp block assembly and canal reamer. (Figure 14) Place the saw blade flat, cutting from lateral to medial, and resect the humeral head. (Figure 15) Figure 14 Note: In certain cases, it may not be possible to place the cutting guide inside the subscapularis. In these cases, the guide may be placed just over the subscapularis, or a standard tenotomy may be performed. Figure 15 15

16 Preparing the Metaphysis With the final canal reamer in place, select the corresponding body sizing osteotome. Using the flats on the canal reamer, attach the osteotome to the canal reamer and slide it down the shaft. (Figure 16) Using the T-Handle, adjust the reamer until the osteotome rests flat on the resected humerus (Figure 17). This verifies that the inclination of the resection is correct and that the osteotome will follow the retroversion selected during the humeral head resection. Using a mallet, impact the osteotome to the depth of the window (Figure 18). Driving the osteotome into the cancellous bone creates the anterior, posterior, and medial fin tracks. Remove the canal reamer and osteotome. Using a rongeur or an osteotome, remove the outlined cancellous bone. Select the cannulated AFFINITI EH2 broach size that corresponds with the previously used body sizing osteotome. Attach the broach to the humeral impactor and secure by closing the lever. (Figure 19) Be sure to align the tab of the impactor/extractor with pocket of the broach. Align the fins of the broach with the tracks created by the osteotome and impact the broach until the collar rests flush on the cut humerus. (Figure 20) Do not impact the collar into the cancellous bone. Figure 16 Figure 17 Figure 18 Note: The broach is undersized in comparison to the final implant and provides approximately 1 mm of proximal diametric press-fit. In case of poor bone quality, it may be advisable to leave a portion of the medial bone outlined by the body sizing osteotome or add bone graft to mitigate the risk of medialization. Figure 19 Figure 20 16

17 Considerations When Using a Long Stem When using a long stem, the standard body sizing osteotomes and AFFINITI EH2 broaches are used to prepare the proximal humerus. The long stem trials have been designed to precisely represent the implant allowing for accurate trialing. As a result, no additional press-fit will be obtained when implanting the final stem after using the long stem trial. Sizing the Humeral Head and Sculpting the Tuberosities Note: Although it is rare, certain head and stems combinations may not be possible. This is due to the potential interference between the anterior and posterior fins of the stem and the extended portion of the humeral head. If this should occur, it is advisable to downsize and cement the humeral stem. Refer to the reference chart on page 17. With the cannulated AFFINITI EH2 broach in place, place a standard trial head onto the broach to determine which head provides the best coverage. Each humeral head diameter is offered in two thicknesses. The initial thickness of the trial head can be determined by mimicking the thickness of the resected head, except in the case of severe deformity. (Figure 21) With the head diameter of the trial head chosen, select the corresponding size tuberosity reamer. Introduce the tip of the AFFINITI EH2 sterile pin into the broach, and then place the tuberosity reamer over the pin. (Figure 22) Be sure the reamer is spinning prior to engaging the bone. Advance the reamer until it bottoms out on the top of the broach. (Figure 23) Figure 21 Figure 22 Figure 23 17

18 Humeral Head and Stem Options Head & Stem Options Humeral Stem Sizes 6 mm 8 mm 10 mm 12 mm 14 mm 16 mm 18 mm Extended Humeral Head Sizes 44 x 18 Yes Yes Yes Yes Yes No No 44 x 21 Yes Yes Yes Yes Yes No No 48 x 18 Yes Yes Yes Yes Yes Yes No 48 x 21 Yes Yes Yes Yes Yes Yes No 52 x 18 Yes Yes Yes Yes Yes Yes Yes 52 x 21 Yes Yes Yes Yes Yes Yes Yes 56 x 18 Yes Yes Yes Yes Yes Yes Yes 56 x 21 Yes Yes Yes Yes Yes Yes Yes With the broach in place, select the humeral head trial of the determined diameter and thickness and place it onto the broach, aligning the laser mark on the underside of the trial head with the laser mark on the collar of the broach. (Figure 24) Trial Reduction Reduce the humeral head trial. The goal is for an anatomically-sized head reconstruction to create a smooth articulation at both the glenohumeral and humeralacromial interfaces. Instability is generally not a problem because of proximal humerus migration. Removing the Trial When the trial reduction has been successfully completed, the trial head and broach should be removed. If the head is difficult to remove, the head distractor can be positioned between the collar of the broach and the rim of the trial head to aid in removal. Once the head has been removed, the humeral impactor/ extractor is reattached to the broach and the broach is removed from the humerus. Be sure to align the tab of the impactor/extractor with the pocket on the broach. Figure 24 18

19 Humeral Implant Assembly Note: The surgeon should inspect the humeral head and humeral stem tapers for debris or blemishes before assembly. The humeral head should be assembled to the definitive stem with clean gloves in a dry environment. Prior to placing the final stem into the impaction stand, align the laser mark on the underside of the final AFFINITI EH2 head with the medial fin of the stem. Apply pressure to stem and head to engage the Morse taper. (Figure 25) Figure 25 Place the previously engaged head and stem into the impaction stand. The 6, 8, 10 and 12 mm stems have been designed to fit in one end of the impaction stand, and the 14, 16 and 18 mm stems fit in the opposite end of the impaction stand. Note: When assembling a humeral head and long stem implant, place the impactor block near the edge of a table allowing the tip of the stem to overhang the table. With the final stem in the stand, the collar should rest flush on the impaction stand. Place the impactor tip on the impaction handle. Using the impactor and a mallet, impact the head to securely seat the Morse taper. 19

20 Insertion of the Definitive Assembly The final stem is diametrically 1 mm larger than the trial broach and in most cases provides for a firm press-fit without the need for cement. If the trial broach is slightly loose after impaction, use either bone graft from the resected head of the humerus or cement for fixation of the final prosthesis. (Figure 26) If bone graft is used, it is recommended to place the bone graft fragments into the metaphyseal region. Frequently, this is placed on the medial neck, which helps lateralize the final position of the stem. Use the broach and trial impactor/extractor to firmly compact the graft. Do not advance the broach beyond the level of resection. The decision to use cement or a press-fit technique is based upon individual surgeon preference. In some instances, it may be necessary to use cement. The cemented technique will vary depending on the indication of each surgery. If cement is utilized, a distal cement restrictor should be placed 1-2 cm beyond the tip of the humeral stem to prevent cement extravasations into the distal humeral canal. Prior to seating the final humeral assembly, the surgeon must plan the subscapularis tendon reattachment. Figure 26 If the tendon was released leaving a 1 cm stump attached on the lesser tuberosity, the humeral implant may be inserted directly, and the subscapularis repaired to the stump utilizing multiple #2 nonabsorbable sutures in a Figure-eight fashion. However, if a lesser tuberosity osteotomy was performed, drill three or four holes into the neck of the remaining humerus at the lesser tuberosity attachment point. A suture passer facilitates placing #2 nonabsorbable sutures through these holes, and out through the neck of the humerus, for securing the lesser tuberosity osteotomy. This must be completed prior to inserting the final humeral implant. After the final humeral prosthesis is seated, these sutures are passed through the subscapularis tendon, and around the lesser tuberosity osteotomy fragment, allowing for a secure repair. Regardless of the cemented or press-fit method used, place the assembled final prosthesis down the intramedullary canal by hand. Use the impactor tip and impactor handle to seat the final assembly. 20

21 Closure After the final implants are in position and the shoulder has been reduced, the subscapularis is repaired to the remaining 1 cm portion at the lesser tuberosity. This should be completed with #2 nonabsorbable suture in a Figureeight fashion if a tag has been left at the lesser tuberosity, or through a drill hole in the anterior humeral neck if a tag has not been left. If the subscapularis has been left completely intact, no closure is necessary. If a hemovac drain is utilized, it can be placed through the deltoid and into the subacromial space. The deltopectoral interval is closed with #1 absorbable suture taking care not to injure the cephalic vein. If it is lacerated or injured, it should be ligated with suture rather than bovi cautery. Skin closure is performed according to the surgeon s preference with either suture or staples. Post Operative Rehabilitation Remove sling and hemovac drain the first morning after surgery. Begin active assisted forward elevation and external rotation on the first day after surgery unless the patient has had chronic problems with large effusions. The risk of stiffness following this operation is low. It is better to have wound healing without drainage than to aggressively attempt early mobilization. Place no limit to forward elevation, but limit external rotation to the side to 40 degrees. If the subscapularis has been left intact, one may utilize the same regimen, but no restrictions are necessary and strengthening can begin relatively quickly, depending upon the surgeon s discretion. At two weeks, begin internal rotation stretching. Encourage active use of the arm for activities of daily living. At 8 weeks, begin active shoulder strengthening as necessary. Note: The guidelines listed above were established by fellowship trained shoulder surgeons and provides a framework for post operative rehabilitation. 21

22 Instruments A I H D J B C E F G L K Humeral Top Tray Instrument Reference Description A T-Handle w/ Hudson End B IM Guide Pins C Retroversion Rod D IM Guide Member E IM Clamp Arm F IM Clamp Body G IM Clamp Screw H Humeral Flat Plate Cutting Guide I mm Humeral Canal Reamer I mm Humeral Canal Reamer I mm Humeral Canal Reamer I mm Humeral Canal Reamer I mm Humeral Canal Reamer I mm Humeral Canal Reamer I mm Humeral Canal Reamer J Plastic Darrach K Crego Retractor L AFFINITI Pin Puller 22

23 E A B C D Humeral Middle Tray Instrument Reference Description A mm Humeral Osteotome A mm Humeral Osteotome A mm Humeral Osteotome A mm Humeral Osteotome A mm Humeral Osteotome A mm Humeral Osteotome A mm Humeral Osteotome B Humeral Impactor/Extractor C Plastic Tip for Humeral Impactor/Extractor D Metal Tip for Humeral Impactor/Extractor E mm Humeral Broach E mm Humeral Broach E mm Humeral Broach E mm Humeral Broach E mm Humeral Broach E mm Humeral Broach E mm Humeral Broach 23

24 A E G F B C H D Humeral Bottom Tray Instrument Reference Description A X 15 Std. Humeral Head Trial A X 18 Std. Humeral Head Trial A X 21 Std. Humeral Head Trial A X 15 Std. Humeral Head Trial A X 18 Std. Humeral Head Trial A X 21 Std. Humeral Head Trial A X 15 Std. Humeral Head Trial A X 18 Std. Humeral Head Trial A X 21 Std. Humeral Head Trial A X 15 Std. Humeral Head Trial A X 18 Std. Humeral Head Trial A X 21 Std. Humeral Head Trial A X 15 Std. Humeral Head Trial A X 18 Std. Humeral Head Trial A X 21 Std. Humeral Head Trial B Eccentric Head Trial Screwdriver Instrument Reference Description C Humeral Head Distractor D Humeral Trial Extractor E Head/Stem Impactor Block F X 18 Ecc. Humeral Head Trial F X 21 Ecc. Humeral Head Trial F X 18 Ecc. Humeral Head Trial F X 21 Ecc. Humeral Head Trial F X 18 Ecc. Humeral Head Trial F X 21 Ecc. Humeral Head Trial F X 18 Ecc. Humeral Head Trial F X 21 Ecc. Humeral Head Trial F X 18 Ecc. Humeral Head Trial F X 21 Ecc. Humeral Head Trial G Humeral Head Impactor Shaft H Humeral Head Impactor Tip 24

25 G F D H E I A A A A C B B B B Extended Head Humeral Tray Instrument Reference Description A x 18 AFFINITI EH2 Trial A x 21 AFFINITI EH2 Trial A x 18 AFFINITI EH2 Trial A x 21 AFFINITI EH2 Trial A x 18 AFFINITI EH2 Trial A x 21 AFFINITI EH2 Trial A x 18 AFFINITI EH2 Trial A x 21 AFFINITI EH2 Trial B mm Tuberosity Reamer B mm Tuberosity Reamer B mm Tuberosity Reamer B mm Tuberosity Reamer C mm AFFINITI EH2 Broach C mm AFFINITI EH2 Broach C mm AFFINITI EH2 Broach C mm AFFINITI EH2 Broach Instrument Reference Description C mm AFFINITI EH2 Broach C mm AFFINITI EH2 Broach C mm AFFINITI EH2 Broach D Lateral Cut Guide - Knob E Lateral Cut Guide - Cut Block Sz1 E Lateral Cut Guide - Cut Block Sz2 F Lateral Cut Guide - Clamp Block G Lateral Cut Guide - Arm H Guide Pins I Retroversion Rod Note: A Long Stem Trial Tray is available upon request mm Humeral Long Stem Trial mm Humeral Long Stem Trial mm Humeral Long Stem Trial mm Humeral Long Stem Trial *The AFFINITI EH2 Sterile Guide Pin (Catalog No ) is single use only and provided separately from the instrument tray. 25

26 Standard Humeral Stems Catalog # Description mm Std Humeral Stem mm Std Humeral Stem mm Std Humeral Stem mm Std Humeral Stem mm Std Humeral Stem mm Std Humeral Stem mm Std Humeral Stem Long Humeral Stems Catalog # Description mm Humeral Long Stem mm Humeral Long Stem mm Humeral Long Stem mm Humeral Long Stem Long Humeral Stems Catalog # Description x 18 AFFINITI EH x 21 AFFINITI EH x 18 AFFINITI EH x 21 AFFINITI EH x 18 AFFINITI EH x 21 AFFINITI EH x 18 AFFINITI EH x 21 AFFINITI EH 2 26

27 Notes 27

28 1023 Cherry Road Memphis, TN Nesbitt Avenue South Bloomington, MN Proper surgical procedures and techniques are the responsibility of the medical professional. This material is furnished for information purposes only. Each surgeon must evaluate the appropriateness of the material based on his or her personal medical training and experience. Prior to use of any Tornier implant system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications, and adverse effects. Package inserts are also available by contacting Wright. Contact information can be found in this document and the package insert. and denote Trademarks and Registered Trademarks of Wright Medical Group N.V. or its affiliates Wright Medical Group N.V. or its affiliates. All Rights Reserved. CAW-4266 REV B ECN May-2016