GLOBAL STEPTECH SURGICAL TECHNIQUE. Anchor Peg Glenoid ANCHOR PEG GLENOID

Transcription

1 GLOBAL STEPTECH Anchor Peg Glenoid SURGICAL TECHNIQUE ANCHOR PEG GLENOID STEPTECH

2

3 CONTENTS Posterior Glenoid Erosion 4 SURGICAL TECHNIQUE Key Surgical Steps 5 Pre-Operative Planning 6 Glenoid Exposure 7 Pin Placement 8 Adjustable Pin Guide 9 Pin Guide and Sizing Fixed Pin Guide 12 Anterior Reaming Normal Exposure 13 Anterior Reaming Challenging Exposure Drilling Central Peg Hole and Guide Pin Extraction 16 Posterior Preparation Bone Preparation Assessment and Tamping 20 Drilling Peripheral Peg Holes Trialing 23 Applying Bone Paste 24 Cement Application Seating Implant and Bone Graft Shaper 27 KEY INFORMATION Instrument Case Layout Ordering Information Essential Product Information and References 32 Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 3

4 POSTERIOR GLENOID EROSION Asymmetric wear can lead to increased reduction of the posterior surface of the glenoid fossa. It is estimated 25 to 40% of patients with end-stage osteoarthritis have excessive posterior wear. 1 Studies show asymmetric wear can result in increased retroversion of 12.5 degrees in osteoarthritic patients. 2 This abnormal condition can be addressed at the time of total shoulder arthroplasty possibly leading to improved joint stability, and decreased risk of implant loosening. 3,4 However, current treatment options show limited success, add significant time to the surgical procedure, and can compromise healthy bone. In primary glenohumeral osteoarthritis (GHOA), Walch et al. utilized a glenoid classification system that differentiated retroversion between posterior erosion and dysplasia (A1, A2, B1, B2, C). 2 A1 B1 C A2 B2 OPTIONS TO CORRECT THESE ABNORMAL CONDITIONS INCLUDE THE FOLLOWING: Asymmetric Reaming Spherical reamers remove excess healthy bone, resulting in a medialization of the joint plane. This procedure does not replicate the natural location of the original glenoid surface, possibly causing insufficient implant support for certain patients. Where excessive reaming may result in severe bone loss, leaving the glenoid with asymmetric wear has demonstrated a high clinical failure rate. 3 Bone Graft and Implant Bone graft, typically from the humeral head, is secured to the posterior segment of the glenoid with multiple screws. A polyethylene implant is placed into the new glenoid surface through a standard procedure. This lengthy procedure may ultimately increase the risk of malunion and subsequent component loosening. 4 4 DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

5 KEY SURGICAL STEPS Adjustable Pin Guide Normal Exposure Sizer Pin Guide Challenging Exposure Fixed Pin Guide 3. Drilling Central Peg Hole 2. Anterior Reaming 1. Pin Placement 4. Posterior Preparation 5. Drilling Peripheral Peg Holes 6. Trialing 7. Applying Bone Paste 8. Seating the Implant Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 5

6 PRE-OPERATIVE PLANNING Obtain a thin cut (1mm) axial CT scan with the gantry positioned perpendicular to the plane of the scapula for all patients. A single axial slice just below the mid equator of the glenoid fossa should be selected for measurement of glenoid version as described by Friedman et al. (Figure 1). 5 The desired amount of correction should be determined and individualized using the patient s version measurement. Correction without Hypoplasia In patients with acquired bone loss secondary to arthritis, correction to a retroversion angle of 5 to 6 degrees will allow most patients to attain an approximate native version while minimizing risk of over-correction. For example, if pathologic retroversion is measured at 16 degrees, a correction of only 10 degrees should culminate in a stable new range of motion for the patient. Correction with Hypoplasia When glenoid hypoplasia exists, full correction to neutral version will often result in over-tightening of the posterior soft tissues and significant loss of internal rotation. In these cases the amount of correction is difficult to predict pre-operatively and should be determined at the time of surgery and individualized to the patient based upon the degree of posterior capsule tightness. Figure 1 Step Height The same CT slice used to measure version should be used to identify the plane of the scapula. Once identified, the distance from the plane of the scapula to the posterior-most portion of the glenoid fossa should be measured in millimeters to help plan for which implant step height will be needed (Figure 2). Figure 2 6 DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

7 GLENOID EXPOSURE Soft tissue is dissected and retracted to allow access to the glenoid. Full 360 degree exposure of the bony glenoid should be achieved. Please refer to the GLOBAL ENABLE Glenoid Exposure System Design Rationale and Surgical Technique ( ). Figure 3 Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 7

8 PIN PLACEMENT The focal point of the early stages of this procedure is the 2.5mm Breakaway Guide Pin. Once set in the center of the glenoid fossa, the 2.5mm Breakaway Guide Pin serves as both a location reference and a guide for the cannulated instruments (Figure 4). The 2.5mm Breakaway Guide Pin needs to be set in an orientation that provides the appropriate amount of retroversion correction by using one of the three pin placement devices: Adjustable Pin Guide Sizer Pin Guide (40+3, 40+5, 40+7, 44+3, 44+5, 44+7, 48+3, 48+5, 48+7, 52+3, 52+5, 52+7, 56+3, 56+5, or 56+7mm) Fixed Pin Guide Figure 4 The length of the 2.5mm Breakaway Guide Pin can be adjusted at three scored locations, which allow for smooth and controlled breakage (Figure 5). NOTE: The grooves on the 2.5mm Breakaway Guide Pin are exclusively used for the breakaway feature and are not intended to indicate the depth to which the pin should be inserted. The pin is designed to break at the grooves. Be aware that it may break unintentionally if subjected to too much bending force. After use of the guide pin is complete, confirm that all sections (totaling the full length of the original, unbroken pin) have been removed. Figure 5 8 DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

9 ADJUSTABLE PIN GUIDE During pre-operative planning determine the desired angle of version correction, as well as the distance from the anterior-most portion of the glenoid fossa to its center before using the Adjustable Pin Guide. Either use a standard protractor or position the Adjustable Pin Guide using the CT scan printout as a guide to set the desired angle. Align the adjustable base of the pivoting face-rest with the line that corresponds to the desired angle of correction while making sure the straight portion of the Adjustable Pin Guide shaft is co-linear with the zero degree vertical plane of the protractor or the perpendicular plane of the scapula. Tighten the adjustment screw in place using the 3.5mm Hex Driver (Figure 6). Figure 6 Position the Adjustable Pin Guide slightly inferior to the midpoint of the glenoid fossa so that the face-rest lies flat against the articulating surface of the glenoid and the metal extension on the base of the face-rest contacts the anterior surface of the glenoid fossa (Figure 7). Figure 7 Locate the most appropriate row of pin placement holes based on the measured distance from the anterior-most portion of the glenoid fossa to the plane of the scapula. Drill the 2.5mm Breakaway Guide Pin through the Adjustable Pin Guide and into the glenoid fossa (Figure 8). Figure 8 Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 9

10 SIZER PIN GUIDE AND SIZING Sizer Pin Guide During pre-operative planning determine the desired angle of version correction before using the Sizer Pin Guide (40+3, 40+5, 40+7, 44+3, 44+5, 44+7, 48+3, 48+5, 48+7, 52+3, 52+5, 52+7, 56+3, 56+5, or 56+7mm). Based on this information, choose the most appropriate step height for the patient (See Table 1 and Figure 9). Figure 9 Sizing Choose the most appropriate implant size (40, 44, 48, 52, and 56mm) for the patient. Identify which Sizer Pin Guide covers as much of the glenoid surface as possible without overhanging the periphery of the bone surface (Figure 14). The translucent material of the Sizer Pin Guide facilitates visualization of position and fit. If there is intraoperative difficulty in glenoid sizing, reference the planned size for the humeral head to determine which side of the joint needs to be adjusted. Note: A glenoid implant that is too large will lack glenoid bone support and interfere with normal rotator cuff function. Anterior Reaming 5 Step Height Table 1 Version Correction (approximate) Total Correction +3mm mm mm DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

11 SIZING Once both the size and step height have been determined, affix the corresponding Sizer Pin Guide to the Curved Handle to center it on the glenoid fossa with the step oriented posteriorly. Insert a 2.5mm Breakaway Guide Pin through the Curved Handle/Sizer Pin Guide assembly and drill securely into the glenoid fossa using a power drill (Figure 10). Figure 10 Remove the Curved Handle/Sizer Pin Guide assembly over the 2.5mm Breakaway Guide Pin or remove the Sizer Pin Guide utilizing the posterior slot (Figure 11). Figure 11 The 2.5mm Breakaway Guide Pin length may be adjusted at this point by placing the guide pin through the hole in the top of the Curved Handle just below the chosen score line and snapping the guide pin using the Curved Handle as a lever (Figure 12). The guide pin is now ready for the other cannulated instrumentation. Figure 12 Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 11

12 FIXED PIN GUIDE The Fixed Guide Pin does not require any pre-operative planning. Insert the tip of the Straight Handle Hex Driver through the top of the Fixed Pin Guide and engage it in the bottom portion. Tighten the Internal Rod of the Straight Handle Hex Driver through the External Handle, which expands the hexagonal tip to secure the driver to the Fixed Pin Guide (Figure 13). Figure 13 Place the guide along the anterior wall of the glenoid until its tip reaches the lateral aspect of the subscapularis fossa. Identify the hole in the upper portion of the Fixed Pin Guide that will guide a pin toward the center of the glenoid fossa (Figure 14). Care needs to be taken that the inclination angle of the Fixed Guide Pin is oriented appropriately. Figure 14 Insert a 2.5mm Breakaway Guide Pin through the chosen hole of the Fixed Pin Guide directly and securely into the glenoid fossa (Figure 15). Loosen the Internal Rod of the Straight Handle Hex Driver to disengage it from the Fixed Pin Guide (Figure 15 Inset). Remove the Fixed Pin Guide from the glenoid by grasping the upper portion and allowing the lower portion to pivot around the anterior glenoid. If sizing was not performed in the pin placement step, perform it now. Note: The Fixed Pin Guide is designed to place the guide pin straight down the axis of the glenoid regardless of version. Inclination must be independently determined and set by the surgeon. Figure DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

13 ANTERIOR REAMING NORMAL EXPOSURE Attach the appropriately sized Access Reamer (40, 44, 48, 52, or 56mm) to the Quick Connect Driver Shaft, and advance both over the 2.5mm Breakaway Guide Pin (Figure 16). Initiate power before the reamer contacts the glenoid and then ream until the entire anterior surface of the glenoid (from approximately 6 o clock to 12 o clock) forms an even, concave surface. The approximate 6 o clock to 12 o clock vertical boundary should be even with, or slightly posterior to, the 2.5mm Breakaway Guide Pin (Figure 17). Figure 16 Remove the Access Reamer and Quick Connect Driver Shaft over the 2.5mm Breakaway Guide Pin. Detach the Access Reamer from the Quick Connect Driver Shaft to ready the driver for the drilling step. Note: It is important to prepare the anterior surface completely before moving on to the next step to ensure congruent contact between the bone and the back side of the implant. Caution Over-reaming decreases the surface area of the glenoid, decreases the depth of the glenoid vault, and removes the subchondral bone. All of these conditions can lead to suboptimal seating and support of the implant. Figure 17 Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 11

14 ANTERIOR REAMING CHALLENGING EXPOSURE In cases where exposure is a challenge, a two-step reaming process may be helpful. The small size and unique shape of the Low Profile Central Reamer (40/44mm or 48/52/56mm) improves access to the glenoid. The smaller diameter is designed to cover the glenoid from anterior to posterior, and therefore, leaves cartilage and bone behind superiorly and inferiorly (Figure 18). This must then be removed with a Low Profile Peripheral Reamer (40, 44, 48, 52, or 56mm), which is also sized and shaped for easy insertion into the joint. Figure DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

15 ANTERIOR REAMING CHALLENGING EXPOSURE Attach the appropriately sized Low Profile Central Reamer to the Quick Connect Driver Shaft, and advance both over the 2.5mm Breakaway Guide Pin. Initiate power before the reamer contacts the glenoid and then ream until an even, concave surface reaches from the anterior portion of the glenoid to the guide pin in the center. Remove the Low Profile Central Reamer and Quick Connect Driver Shaft over the 2.5mm Breakaway Guide Pin. Detach the Low Profile Central Reamer from the Quick Connect Driver Shaft to ready the driver for the drilling step. Select the appropriately sized Low Profile Peripheral Reamer, and attach it to the Ratchet T-Handle from either the GLOBAL ADVANTAGE or GLOBAL AP Shoulder Replacement Systems instrument sets. Insert the Low Profile Peripheral Reamer over the guide pin, and manually rotate it back and forth until its depth-stop bottoms out on the central portion of the glenoid (Figure 19). The result should be an even, concave surface across the entire anterior surface (from 6 o clock to 12 o clock) of the glenoid. Figure 19 Note: The approximate 6 o clock to 12 o clock vertical boundary should be even with, or slightly posterior to, the 2.5mm Breakaway Guide Pin. Caution The Low Profile Peripheral Reamer is not intended for use with power. If hard bone impedes bone removal, a burr may be used to conservatively remove problem areas. Care should be taken to avoid removal of too much subchondral bone as this may compromise implant stability. Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 11

16 DRILLING CENTRAL PEG HOLE AND GUIDE PIN EXTRACTION Drilling Central Peg Hole Attach the appropriately sized cannulated Quick Connect Central Drill Bit (+3, +5, or +7mm) to the Quick Connect Driver Shaft, and introduce both over the 2.5mm Breakaway Guide Pin. Advance the bit until it bottoms out on the reamed surface of the glenoid (Figure 20). The morselized bone captured during drilling the central hole should be saved for use as bone paste between the flutes of the Anchor Peg Glenoid. Remove the Quick Connect Central Drill Bit and Quick Connect Driver Shaft over the 2.5mm Breakaway Guide Pin (Figure 21). Note: Ensure that the Quick Connect Central Drill Bit fully bottoms out on the anterior glenoid surface by removing any debris created as the drill bit is advanced. Guide Pin Extraction Grasp and remove the 2.5mm Breakaway Guide Pin using the Pin Extractor (Figure 22). Figure 20 NOTE: After use of the guide pin is complete, confirm that all sections (totaling the full length of the original, unbroken pin) have been removed. Figure 21 Figure DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

17 POSTERIOR PREPARATION Insert the appropriately sized Rasp Guide (+3, +5, +7mm, SM or LG) into the central drill hole (Figure 23). The posterior edge of the guide defines the vertical boundary between the anterior and posterior portions of the glenoid. The guide also serves to protect the prepared anterior surface and the central drill hole. If necessary, impact the Rasp Guide with the Universal Glenoid Handle and Glenoid Impactor Tip to firmly seat the guide on the anterior surface of the glenoid (Figure 24). Option: An alternative method to secure the Rasp Guide in place is to use two 2.5mm x 70mm Fixation Pins. Insert two 2.5mm x 70mm Fixation Pins through the angled holes of the Rasp Guide directly and securely into the glenoid fossa (Figure 25). Figure 23 Figure 24 Figure 25 Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 11

18 POSTERIOR PREPARATION Select the matching sized Oscillating Rasp (+3, +5, 7mm, SM or LG) and connect to an appropriate power source. Create the desired posterior glenoid surface geometry to match the implant. Using a pendulum motion advance the Oscillating Rasp medially until the anterior stop contacts the surface of the Rasp Guide (Figure 26). Once completed, remove both the Oscillating Rasp and the Rasp Guide. Note: There must be congruent contact between the posterior surface of the glenoid and the back side of the implant. It is important to keep the handpiece of the power source perpendicular, or slightly anterior, relative to the Rasp Guide to remove the proper amount of bone to support the implant. Figure 26 Caution Tilting the handpiece too much posteriorly may remove more bone than desired. Note: There may be times when the posterior bone is sclerotic requiring the use of a burr to remove some of the hard bone before using the Oscillating Rasps (Figure 27). Figure DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

19 POSTERIOR PREPARATION Option: An alternative method for preparing the posterior surface of the glenoid would be to use the appropriately sized Superior/Inferior Scraper (+3L, +3R+5, +7 mm, L or R). The Superior/Inferior Scraper is advanced medially using a sweeping motion until it bottoms out at the correct depth (Figure 28). Figure 28 Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 11

20 BONE PREPARATION ASSESSMENT AND TAMPING Determine whether the created bony surfaces are sufficient for accepting the implant by using the appropriately sized Bone Preparation Assessor (40+3, 40+5, 40+7, 44+3, 44+5, 44+7, 48+3, 48+5, 48+7, 52+3, 52+5, 52+7, 56+3, 56+5, or 56+7mm) that accurately mimics the backside surfaces of the implant (Figure 29). The Bone Preparation Assessor should make full and concentric contact with the prepared glenoid surfaces, being firmly seated without a tendency to lift off or wobble. Figure 29 If high spots on the bone are preventing the Bone Preparation Assessor from seating properly, the Universal Glenoid Handle and Glenoid Impactor Tip can be used to tamp the assessor to make the prepared glenoid surfaces more conforming (Figure 30). Check the fit of the Bone Preparation Assessor again. If the fit is still not desirable, some or all of the prior bone preparation steps may need to be repeated. Note: It is important to ensure proper alignment of the Bone Preparation Assessor before tamping to avoid crushing the vertical step. Figure DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

21 DRILLING PERIPHERAL PEG HOLES Insert the tip of the Straight Handle Hex Driver into one of the hexagonal holes on the Peripheral Drill Guide (+3, +5, +7mm, L or R). Tighten the Internal Rod of the Straight Handle Hex Driver expanding the hexagonal tip and securing the driver to the Peripheral Drill Guide. Insert the Peripheral Drill Guide into the central hole making sure it fully contacts the anterior and posterior prepared bone surfaces (Figure 31). Insert a 2.5mm x 70mm Fixation Pin through the anterior fixation pin hole for additional stability if needed (Figure 32). Figure 31 Connect the Quick Connect Peripheral Drill Bit (Anterior, Superior/Posterior +3, +5 or +7mm) to the Quick Connect Driver Shaft. Color-coding on the Peripheral Drill Guide and Quick Connect Peripheral Drill Bit indicates which drill bits should be used through which holes. It is recommended that the anterior hole is drilled first, followed by the posterior/inferior hole and lastly the superior hole (Figure 32). This helps to direct that the peripheral holes are prepared to the appropriate depths, based on the final implant s step height. The peripheral holes should not penetrate the base of the scapula Figure 32 Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 22

22 DRILLING PERIPHERAL PEG HOLES Drill one of the peripheral peg holes and place the corresponding Anti-Rotation Peg (Anterior, Superior/ Posterior +3, +5, or +7mm) (Figure 33) into the newly drilled peripheral hole using the Anti-Rotation Peg Inserter/Remover. The peg will help prevent the Peripheral Drill Guide from shifting or rotating during the drilling of subsequent holes. This will ultimately enable the resulting peripheral hole pattern to precisely accommodate the peripheral pegs of the implant. Prepare the remaining two holes using the same technique. Figure 33 Remove the color-coded Anti-Rotation Peg using the Anti- Rotation Peg Inserter/Remover (Figure 34). Remove the 2.5mm x 45mm Fixation Pin (if applicable), and remove the Peripheral Drill Guide (Figure 35). Note: Drilling the superior hole first is not recommended because the superior hole spans the superior/inferior step in the bone. The Peripheral Drill Bit seeks the path of least resistance (toward the posterior portion of the glenoid where bone has already been removed), which results in the guide having a greater tendency to rotate during the drilling of this hole than during the drilling of others. Therefore, it is recommended that the superior hole not be drilled until an Anti-Rotation Peg has been placed in one of the other peripheral holes. Figure 34 Note: Check each peripheral hole to determine whether it penetrates the cortical wall of the glenoid vault. Penetrating holes are cemented, but extra care must be exercised to avoid pressurizing the cement. Figure DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

23 TRIALING Insert the appropriate implant Trial (40+3, 40+5, 40+7, 44+3, 44+5, 44+7, 48+3, 48+5, 48+7, 52+3, 52+5, 52+7, 56+3, 56+5, or 56+7mm, L or R) (Figure 36) into the prepared glenoid using the Glenoid Grasper (Figure 37). Assess the fit to determine that the Trial sits flush with the prepared surface of the glenoid. There should be full and concentric contact between the back side of the Trial and the prepared surface of the bone. If there is not full and concentric contact between Trial and prepared bone surface, some or all of the prior bone preparation steps may need to be repeated. If the fit is adequate, remove the Trial, and finalize the bone preparation with pulsatile lavage or other means of thorough irrigation to remove any blood clots from the four drilled holes. Note: Check the quality of the glenoid bone preparation by determining if the component is directly supported by precisely contoured bone, which should prevent the component from rocking, even when an eccentric load is applied to the rim of the implant. Note: Complete humeral implantation according to the GLOBAL ADVANTAGE ( ), GLOBAL ADVANTAGE + ( ), or GLOBAL AP ( ) Systems surgical technique. Verify soft tissue tension and range of motion after completing the humeral procedure. Figure 36 Caution Component loosening or excessive wear may occur if the glenoid component lacks sufficient bone support. Figure 37 Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 22

24 APPLYING BONE PASTE Use the Bone Graft Applicator to apply cancellous bone paste between the flutes of the appropriately sized GLOBAL STEPTECH Anchor Peg Glenoid (40+3, 40+5, 40+7, 44+3, 44+5, 44+7, 48+3, 48+5, 48+7, 52+3, 52+5, 52+7, 56+3, 56+5, 56+7mm, L or R) to help facilitate tissue integration. Place the GLOBAL STEPTECH Anchor Peg Glenoid implant on a table with the articular surface down and the central peg flutes up. Place the circular opening of the Bone Graft Applicator over the flutes, and open the handles to expose the central peg flutes. Place the bone paste collected from the drilling of the central peg hole into the Bone Graft Applicator on both sides of the central peg flutes (Figure 38). Close and hold the Bone Graft Applicator. At the same time, hold the GLOBAL STEPTECH Anchor Peg Glenoid implant at its base, and twist the Bone Graft Applicator several times back and forth (Figure 39). Pull the Bone Graft Applicator straight off of the GLOBAL STEPTECH Anchor Peg Glenoid, leaving bone interposed evenly between the central peg flutes (Figure 40). Figure 38 Figure 39 Figure DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

25 CEMENT APPLICATION Obtain hemostasis in each of the three peripheral holes. Mix cement as indicated in SMARTMIX Mini System protocol (Figure 41). Replace mixing blade with the plunger. Orient the mixing cartridge horizontally with the syringe port facing up. Remove any unwanted air from the cartridge by advancing the cement until it has reached the port. Securely connect the syringe to the port. Fill the syringe with cement (Figure 42). When cement has reached a doughy state and no longer sticks to surgical gloves, it is ready for use. Figure 41 Figure 42 Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 22

26 CEMENT APPLICATION Use the SMARTMIX Mini Cement Applicator to place three measured half turns of SMARTSET HV Cement into each peripheral hole (Figure 43). Only a small amount of cement is necessary in each hole to provide the proper 1mm cement mantle around each GLOBAL Anchor Peg Glenoid peripheral peg (Figure 44). Make sure no cement is in the central hole or on the backside of the implant that could inhibit proper seating. Note: Excessive cement extruding from the drilled holes and lying between the prosthesis and glenoid fossa is undesirable. It may create an uneven mantle for the glenoid prosthesis, and cement may fragment with repetitive loading and become loose in the joint causing damage to the polyethylene surface. Figure 43 Figure DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

27 SEATING THE IMPLANT Introduce the final implant using the Glenoid Grasper (Figure 45). Figure 45 Use both the Universal Glenoid Handle and the poly Glenoid Impactor Tip to seat the implant until there is complete contact between the back side of the implant and the prepared glenoid surface (Figure 46). The implant will be most stable when supported by precisely contoured bone. This support should prevent rocking even with unbalanced loads applied to the rim of the implant. Maintain direct pressure on the implant until the cement has hardened. Note: Confirm that the central hole is clear prior to implant insertion. Figure 46 Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 22

28 INSTRUMENT CASE LAYOUT Step Prep Tray Sizer Pin Guide 40+7mm Sizer Pin Guide 44+7mm Sizer Pin Guide 48+7mm Sizer Pin Guide 52+7mm Sizer Pin Guide 56+7mm Sizer Pin Guide 40+9mm Sizer Pin Guide 44+9mm Sizer Pin Guide 48+9mm Sizer Pin Guide 52+9mm Sizer Pin Guide 56+9mm Rasp Guid Small +3mm Rasp Guid Small +5mm Rasp Guid Small +7mm Rasp Guide Large+3mm Rasp Guide Large +5mm Rasp Guide Large +7mm Central Drill Bit +3mm Central Drill Bit +5mm Central Drill Bit +7mm Bone Prep Assessor 40+3mm Bone Prep Assessor 40+5mm Bone Prep Assessor 40+7mm Bone Prep Assessor 44+3mm Bone Prep Assessor 44+5mm Bone Prep Assessor 44+7mm Bone Prep Assessor 48+3mm Bone Prep Assessor 48+5mm Bone Prep Assessor 48+7mm Bone Prep Assessor 52+3mm Bone Prep Assessor 52+5mm Bone Prep Assessor 52+7mm Bone Prep Assessor 56+3mm Bone Prep Assessor 56+5mm Bone Prep Assessor 56+7mm 22 DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

29 Peg Prep Tray Glenoid Grasper Peripheral Drill Guide +3mm Right Peripheral Drill Guide +5mm Right Peripheral Drill Guide +7mm Right Peripheral Drill Guide +3mm Left Peripheral Drill Guide +5mm Left Peripheral Drill Guide +7mm Left Peripheral Drill Bit Posterior/Superior +3mm Peripheral Drill Bit Posterior/Superior +5mm Peripheral Drill Bit Posterior/Superior +7mm Anti-Rotation Peg Posterior/Superior +3mm Anti-Rotation Peg Posterior/Superior +5mm Anti-Rotation Peg Posterior/Superior +7mm Trial 40+3mm Right Trial 40+5mm Right Trial 40+7mm Right Trial 44+3mm Right Trial 44+5mm Right Trial 44+7mm Right Trial 48+3mm Right Trial 48+5mm Right Trial 48+7mm Right Trial 52+3mm Right Trial 52+5mm Right Trial 52+7mm Right Trial 56+3mm Right Trial 56+5mm Right Trial 56+7mm Right Trial 40+3mm Left Trial 40+5mm Left Trial 40+7mm Left Trial 44+3mm Left Trial 44+5mm Left Trial 44+7mm Left Trial 48+3mm Left Trial 48+5mm Left Trial 48+7mm Left Trial 52+3mm Left Trial 52+5mm Left Trial 52+7mm Left Trial 56+3mm Left Trial 56+5mm Left Trial 56+7mm Left Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 22

30 ORDERING INFORMATION Left Implants STEPTECH APG 40+3mm Left STEPTECH APG 40+5mm Left STEPTECH APG 40+7mm Left STEPTECH APG 44+3mm Left STEPTECH APG 44+5mm Left STEPTECH APG 44+7mm Left STEPTECH APG 48+3mm Left STEPTECH APG 48+5mm Left STEPTECH APG 48+7mm Left STEPTECH APG 52+3mm Left STEPTECH APG 52+5mm Left STEPTECH APG 52+7mm Left STEPTECH APG 56+3mm Left STEPTECH APG 56+5mm Left STEPTECH APG 56+7mm Left Right Implants STEPTECH APG 40+3mm Right STEPTECH APG 40+5mm Right STEPTECH APG 40+7mm Right STEPTECH APG 44+3mm Right STEPTECH APG 44+5mm Right STEPTECH APG 44+7mm Right STEPTECH APG 48+3mm Right STEPTECH APG 48+5mm Right STEPTECH APG 48+7mm Right STEPTECH APG 52+3mm Right STEPTECH APG 52+5mm Right STEPTECH APG 52+7mm Right STEPTECH APG 56+3mm Right STEPTECH APG 56+5mm Right STEPTECH APG 56+7mm Right 33 DePuy Synthes Joint Reconstruction GLOBAL STEPTECH Anchor Peg Glenoid Surgical Technique

31 Case, Trays, Caddies, and Lid Case Complete Case Lid Step Prep Tray Peg Prep Tray Sizer Pin Guide +7mm Caddy Sizer Pin Guide +9mm Caddy DNI DNI 48+3mm DNI 48+5mm DNI 48+7mm Single Use Synvasive Oscillating Rasp Small +3 LINVATEC Synvasive Oscillating Rasp Small +5 LINVATEC Synvasive Oscillating Rasp Small +7 LINVATEC Synvasive Oscillating Rasp Large +3 LINVATEC Synvasive Oscillating Rasp Large +5 LINVATEC Synvasive Oscillating Rasp Large +7 LINVATEC Synvasive Oscillating Rasp Small +3 STRYKER Synvasive Oscillating Rasp Small +5 STRYKER Synvasive Oscillating Rasp Small +7 STRYKER Synvasive Oscillating Rasp Large +3 STRYKER Synvasive Oscillating Rasp Large +5 STRYKER Synvasive Oscillating Rasp Large +7 STRYKER Optional Adjustable Pin Guide mm Hex Driver Superior/Inferior Scraper +3mm Right Superior/Inferior Scraper +5mm Right Superior/Inferior Scraper +7mm Right Superior/Inferior Scraper +3mm Left Superior/Inferior Scraper +5mm Left Superior/Inferior Scraper +7mm Left Anterior/Posterior Scraper Surgical Technique GLOBAL STEPTECH Anchor Peg Glenoid DePuy Synthes Joint Reconstruction 33

32 IMPORTANT: This Essential Product Information sheet does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information. INDICATIONS FOR USE: The GLOBAL STEPTECH Anchor Peg Glenoid is intended for use in total shoulder replacement surgery for patients suffering from: 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon s experience indicates that alternative methods of treatment are unsatisfactory. 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). Glenoid components are intended for cemented use only. WARNINGS AND PRECAUTIONS: The use of a glenoid prosthesis in patients with cuff tear arthropathy could increase the risk of glenoid component loosening due to non anatomic loading conditions. The following conditions tend to adversely affect shoulder replacement implants: excessive patient weight, high levels of patient activity, likelihood of falls, poor bone stock, metabolic disorders, disabilities of other joints. ADVERSE EVENTS: The following are the most frequent adverse events after shoulder arthroplasty: change in position of the components, loosening of components, dislocation, infection, hematoma, pneumonia, and cardiovascular disorders. CONTRAINDICATIONS The following conditions are contraindications for total shoulder and hemi-shoulder arthroplasty. 1. Active local or systemic infection. 2. Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components. 3. Poor bone quality, such as osteoporosis, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid. The following condition is a contraindication for total shoulder arthroplasty. 1. Absent, irreparable or nonfunctional rotator cuff or other essential muscles. References 1. Mullaji AB, Beddow FH, Lamb GH. J Bone Joint Surg Br 1994; 76(3): Walch G, Badet R, Boulahia A, Khoury A. J Arthroplasty 1999; 14(6): Clavert P, Millett PJ, Warner JJ. J Shoulder Elbow Surg 2007; 16(6): Hill JM, Norris TR. J Bone Joint Surg Am 2001; 83-A(6): Wirth MA, Klotz C, Deffenbaugh DL, et al. J Shoulder Elbow Surg 2009; 18(1): Nho SJ, Ala OL, Dodson CC, et al. J Shoulder Elbow Surg 2008; 17(6): Friedman RJ, Hawthorne KB, Genez BM. J Bone Joint Surg Am 1992; 74(7): Matsen III, FA, Iannotti JP, Rockwood Jr. CA. J Bone Joint Surg Am 2003; 85-A(2) Market share data from Millennium Research Group 2011 US Markets for Orthopaedic Extremity Devices (October 2010, RPUS201E10, Norris TR, Iannotti JP. J Shoulder Elbow Surg 2002; 11(2): Jeong J, Bryan J, Iannotti JP. J Bone Joint Surg Am 2009; 91(8): Head WC, Bauk DJ, Emerson Jr. RH. Clin Orthop Relat Res 1995; 311: Limited Warranty and Disclaimer: DePuy Synthes Joint Reconstruction products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. WARNING: In the USA, this product has labeling limitations. See package insert for complete information. CAUTION: USA Law restricts these devices to sale by or on the order of a physician. Not all products are currently available in all markets. DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN T. +1 (800) DePuy Synthes Joint Reconstruction, a division of DOI (Rev. 2) 03/14