This publication is not intended for distribution in the USA. SURGICAL TECHNIQUE

This publication is not intended for distribution in the USA. SURGICAL TECHNIQUE

CONTENTS Introduction 2 Pre-operative Planning 4 Determining the Centre of Rotation 5 Surgical Technique 6 Acetabular Preparation 6 Trialling and Positioning 7 Definitive Placement of the Implant 8 Additional Steps when Implanting a Cup with Legs and Hook 9 Additional Steps when Implanting a Cup with Legs and Hook 10 Insertion of the femoral head into the Polyethylene Insert 11 Post-operative protocol 12 Ordering Information 13 Implants 13 Instruments 14 GYROS Mobile Bearing Cup Surgical Technique DePuy Synthes 1

INTRODUCTION Professor Bousquet from St Etienne in France, first defined the original concept of dual mobility in the early 1970 s. 1 The concept; a prosthetic head mobile within a retentive polyethylene insert, which is free to move within a metal backed cup introduced a new way of treating instabilities in both primary and revision hip arthroplasty. The GYROS Mobile Bearing Cup was developed by the French G.O.S. (Group of Orthopaedic Surgeons from the South of France) with the aim of exploiting the benefits of the mobile bearing concept, whilst also considering the anatomical placement of the cup and the centre of rotation of the hip. Figure 1 2 DePuy Synthes GYROS Mobile Bearing Cup Surgical Technique

1 2 High Stability Low Wear The GYROS Mobile Bearing Cup combines both small and large diameter bearing surfaces. During regular activities, movement is based within the smaller radius (parts 2 and 3), whilst in extremes of motion, where impingement between the smaller head and liner occurs, articulation based about the larger radius (parts 1 and 2). 3 Figure 2 Legs Fixation The mechanical stability of the GYROS dual mobility cup is primarily due to the press fit fixation, the use of an HA coating and equatorial macrostructures. Adjunctive screw fixation for additional stability is available in the legged option of the GYROS dual mobility cup. This cup, which has two iliac legs and an obturator hook allows the surgeon to restore the equatorial plane of the acetabulum, to avoid medialisation, and to naturally reposition the joint centre of rotation in the anatomical position. Obturator Hook The GYROS Cup also features a 15 cylindrical extension of the upper part of the shell to increase liner coverage to reduce the risk of dislocation. Figure 3 GYROS Mobile Bearing Cup Surgical Technique DePuy Synthes 3

PRE-OPERATIVE PLANNING The primary goal of total hip arthroplasty is the accurate restoration of natural joint function. Mechanically, the goals are to create a stable articulation with an optimized range of motion, restore the centre of rotation and offset and equalise limb lengths. The desired magnification for all imaging should be 20 percent, which corresponds to the templates provided for the GYROS hip system. Meeting these goals begins with a thorough analysis of the affected hip compared to the contralateral side in anterior/posterior (A/P) and lateral projections. Preoperative radiographic planning can increase the accuracy of implant placement based on identifiable bony landmarks. This step is crucial in determining the optimal size and position of the acetabulum to restore the center of rotation of the hip. 4 DePuy Synthes GYROS Mobile Bearing Cup Surgical Technique

DETERMINING THE CENTRE OF ROTATION The centre of rotation is determined by tracing the radiological markers on a radiograph of the pelvis, with anteversion such that the position of the tip of the coccyx just above the pubic symphysis. To ensure accurate pre-operative planning when using the GYROS x-ray templates, the following points should be taken into consideration: The shape of the acetabulum Necessary removal of posterior osteophytes Optimal implant coverage ensuring the superior-lateral cup is not excessively uncovered Restoration of the centre of rotation 45 inclination of the implant in relation to the centre of the acetabulum, which is itself determined by the centre of the line drawn through the dense inferior point of the acetabulum (I) and the superior edge of the acetabulum (T) with the removal of eventual osteophytes and 15 of anteversion Planning of the centre of the acetabulum is fundamental to avoid the medialisation of the implant. With respect to the centre of rotation, this will automatically be found due to the legs and hook of the cup which will prevent an excessive medial position from occurring. The GYROS Mobile Bearing Cup can be used with any suitable surgical approach for total hip arthroplasty. Reference points of the pelvis to consider (Figure 4) U : The lower pole of the radiological teardrop S S T : The roof of the acetabulum, at the top of the external angle between the 2 dense lines : subchondral lines of the roof and of the outside of the ilium T CT U I U I CC T I : The upper rim of the sub-acetabular groove, a dense radiological point. S : The lower pole of the sacro-iliac space. CT : The centre of the head. CC : The centre of the bony acetabulum: at the middle of the T-I line. It is essential to plan where the centre of the acetabulum should be in order to avoid medialisation. Figure 4 GYROS Mobile Bearing Cup Surgical Technique DePuy Synthes 5

SURGICAL TECHNIQUE Acetabular Preparation The acetabulum is prepared by: Excision of the labrum. Optional resection of the transverse acetabular ligament (TAL). Careful removal of any posterior osteophytes in order to reproduce the original enclosure of the acetabulum. Careful removal of osteophytes from the roof of the acetabulum up to the original level. Figure 5 The goal of acetabular reaming is to restore the centre of the original acetabulum. Preferentially, the size of the first reamer should be of the same size to that of the removed femoral head. Centre the reamers in the acetabulum and introduce larger reamers sequentially, until the deepened socket becomes a true hemisphere and you have reached vascularised sub-chondral bone. (Figure 5). Use a curette to free all cysts of fibrous tissue, pack any defects densely with cancellous bone. Where the acetabulum is reamed often determines where the cup will seat, it is important to ream where the final cup is to be positioned. As such a part of the reamer head may be visible above the superolateral rim when reaming. It can be helpful to review the x-ray templating to determine the amount of reamer that will be visible. All reamers, trial cups and acetabular cups are line to line (i.e. the same diameter). Usually the final GYROS Cup size is the same as the last reamer size used. The thickness and the mechanical integrity of the acetabular wall must be frequently and carefully checked especially in revision cases. Aim to maintain as much subchondral bone as possible in order to create optimal conditions for mechanical stability (primary stability), as well as biological fixation (integration with the bone). The horns of the acetabulum must be preserved as far as possible in order to ensure an optimal equatorial press-fit. 6 DePuy Synthes GYROS Mobile Bearing Cup Surgical Technique

SURGICAL TECHNIQUE Trialling and Positioning A cup trial the same size as the last reamer used is selected (Figure 6). Cup trials in 2 mm incremental sizes are available to assess cup fit and orientation. The size of the cup trial is as marked on the trial cup (54 mm measures 54 mm). The cup trial should be threaded onto the cup trial inserter at the apex hole. Cup Positioning The cup trial has windows for viewing the reamed acetabulum and the following are carefully checked: Stability - in the equatorial zone. Cup coverage - It is essential to take care that the cup does not overlap the acetabular rim (especially on the anterior side), as this could obstruct the polyethylene insert motion and impinge on the anterior tendons. Figure 6 Orientation Future positions of the two iliac legs and the obturater hook (Legged cup version only) Once the femoral steps have been performed, trial reduction is performed in order to check the stability and mobility of the joint. Note: Sizing of the final insert must match the final cup size. GYROS Mobile Bearing Cup Surgical Technique DePuy Synthes 7

SURGICAL TECHNIQUE Definitive Placement of the Implant In most cases, the size of the definitive GYROS Cup required will be identical to the size of the last reamer used, provided the fit of the trial cup is satisfactory. Sometimes, in the case of porotic bone, the surgeon may implant a definitive cup one size bigger than the last reamer or implant a GYROS Cup with iliac legs, in order to increase primary mechanical stability (see page 7). The final cup impactor allows the surgeon to grasp the cup directly from its packaging. Figure 7 Note: The impaction plate can only be used once. As such it is advised to position the cup on the bottom of the reamed acetabulum for the version without legs, prior to impaction. In the event of loosening of the inserter and impact plate, the surgeon can manually reposition the cup in the acetabulum before it is finally impacted. In order to ensure the implant is fully seated, the tip rim impactor is used to avoid damaging the bearing surface (Figure 8). This is assembled by screwing the impactor onto the threaded section of the impactor handle. Support of the cup must be peripheral in the equatorial zone of the acetabulum. Figure 8 8 DePuy Synthes GYROS Mobile Bearing Cup Surgical Technique

SURGICAL TECHNIQUE Additional Steps when Implanting a Cup with Legs and Hook When implanting a GYROS Cup with iliac legs, it is recommended that when trialling, the position of each leg is marked on the rim of the acetabulum using rongeurs when trialling in order to facilitate impaction, increase the likelihood of good positioning of the implant and to increase rotational stability (Figures 9 and 10). The iliac legs may be adjusted with the leg bender to fit them to the shape of the acetabulum (Figure 11). Note: Repeated bending or similar can potentially weaken the legs, so must be avoided. Prior to impaction of the GYROS Cup with legs, a small osteotome is used to make a hole in the cotyloid/ acetabular notch. The hook guide is then introduced and positioned in the slot created in the bone, which facilitates the insertion of the hook in the obturator hole (Figure 12). Figure 9 Figure 10 Figure 11 Figure 12 GYROS Mobile Bearing Cup Surgical Technique DePuy Synthes 9

SURGICAL TECHNIQUE Additional Steps when Implanting a Cup with Legs and Hook A version guide can be added to the cup impactor to aid cup positioning. Impaction is carried out by tilting the cup from the hook towards the iliac legs, which should fit to the healthy iliac bone (Figure 13). Note: In the event of loosening of the inserter and impact plate, the surgeon can manually reposition the cup in the acetabulum before it is finally impacted using the tip rim impactor (Figure 8). Figure 13 Optional Screws If the press fit is considered sub-optimal, the legged version of the GYROS Cup may be used, with adjunctive screw fixation. Note: Only GYROS Specific Bone Screws are to be used with the GYROS Legged Cup. The holes in the iliac legs accept either cortical screws with a diameter of 4.5 mm or cancellous screws with a diameter of 6.5 mm. These screws are frequently used in revision cases. Drilling is carried out by means of a 3.2 mm drill. The drill guide should be used with the definitive cup to ensure optimal orientation of the drill and protection of soft tissues. A gauge is used to determine the length of the cancellous or cortical screws (Figure 14). Screws are inserted using the hexagonal screwdriver taking care to avoid contact with the back-side of the cup or penetration of the ilium. The screws must be implanted in such a manner as to avoid any conflict with movement of the polyethylene insert in the cup. Figure 14 10 DePuy Synthes GYROS Mobile Bearing Cup Surgical Technique

SURGICAL TECHNIQUE Insertion of the femoral head into the Polyethylene Insert It is recommended that the gun impactor is positioned on a flat table in a vertical position. It is recommended that the femoral head and the inside of the polyethylene insert are clean and free of debris and are also lubricated with physiological serum, before definitive impaction. The gun impaction plate assists correct positioning of the femoral head into the insert. The ceramic or metal femoral head is then placed on the specific impactor plates (the plates are chosen in accordance with neck length). Once the insert is placed onto the head, disengage the rack teeth by turning the shaft and lower the piston until the adaptor stands on the insert. Re-engage by turning back the shaft and activate the trigger until complete impaction of the insert onto the head. Turn the axis by 90 by means of the handle located at the side and free the insert (Figure 15). Figure 15 Clean the stem taper carefully to remove any fluid or particulate debris and dry thoroughly. Place the head insert assembly onto the taper and assemble according to the instructions in the stem/ head surgical technique. Ensure bearing surfaces are clean, and finally reduce the hip (Figure 16). Figure 16 GYROS Mobile Bearing Cup Surgical Technique DePuy Synthes 11

POST-OPERATIVE PROTOCOL The patient should be released from the hospital with complete instructions and notified (if possible in writing) of the precautions to be taken concerning exercises, care and all restrictions on activity as well as those linked to exposure to magnetic fields. A continuing programme of controls must be set up and rigorously applied. The patient s strict observance of the surgeon s instructions and warnings is essential. In every case, the standard instructions must be followed during the postoperative phase. The patient must be encouraged to report any change occurring to the operated limb to his surgeon. If it is believed that a loosening of the prosthesis may have occurred, in particular due to pain and progressive alterations in the x-rays, it is advisable to increase the frequency of the controls; new warnings and instructions concerning additional restrictions on activity may also be given to the patient. Strict observance by the patient of the surgeon s instructions and his warnings is extremely important. In every case, the standard instructions should be followed during the postoperative phase. Excessive physical activity and trauma affecting the operated limb may be the cause of early failure of the arthroplasty through displacement, fracture and/or wear of the implant. The functional duration of prosthetic implants has not been clearly established to date. Periodic follow-up including x-rays are recommended for close comparison with previous post-op conditions to detect long-term evidence of changes in position, loosening, bending, or cracking of components. If evidence of one or more of these conditions is discovered, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of early revision considered. 12 DePuy Synthes GYROS Mobile Bearing Cup Surgical Technique

ORDERING INFORMATION Implants Cups with legs L46544 T44 L46546 T46 L46548 T48 L46550 T50 L46552 T52 L46554 T54 L46556 T56 L46558 T58 L46560 T60 L46562 T62 L46564 T64 L46566 T66 L46568 T68 Cups without legs L47544 T44 L47546 T46 L47548 T48 L47550 T50 L47552 T52 L47554 T54 L47556 T56 L47558 T58 L47560 T60 L47562 T62 L47564 T64 L47566 T66 L47568 T68 22.5 mm ø Inserts 4L46414 T44 4L46416 T46 4L46418 T48 4L46470 T50 4L46472 T52 4L46474 T54 4L46476 T56 4L46478 T58 4L46480 T60 4L46482 T62 4L46484 T64 4L46486 T66 4L46488 T68 28 mm ø Inserts 4L46428 T48 4L46430 T50 4L46432 T52 4L46434 T54 4L46436 T56 4L46438 T58 4L46440 T60 4L46442 T62 4L46444 T64 4L46446 T66 4L46448 T68 Cortical Bone Screws ø 4.5 mm L46620 20 mm L46624 24 mm L46630 30 mm L46634 34 mm L46640 40 mm L46644 44 mm L46650 50 mm L46655 55 mm Cancellous Bone Screws ø 6.5 mm L46745 45 mm L46750 50 mm L46755 55 mm L46760 60 mm L46765 65 mm GYROS Mobile Bearing Cup Surgical Technique DePuy Synthes 13

ORDERING INFORMATION Instruments CALQ827 X-ray Templates 1524-00-000 Hudson Adaptor 2015-24-000 DURALOC Impactor 2274-02-000 Ratchet Handle 2274-04-000 Hexagonal Screwdriver A6417 L46300 L46814 L46739 L46306 L46308 L46740 L95894 M68775 L41070 L46741 L46742 L46743 A6780 A6781 A6782 A6783 A6784 A6785 A6786 Drill Bit ø 3.2 mm x 145 mm Leg Bender Plate Holder Final Cup Impactor Hook Guide Tip Rim Impactor Version Guide Screw Holder Gauge D3,2 Drill Guide Bronze Ring Trial Cup Impactor Impactor Shaft Gun Impactor Handle Gun Impactor Shaft Gun Impactor Shaft Tip Gun Impactor Adaptor Gun Impactor Impaction Plate Gun Impactor Impaction Plate Small Gun Impactor Impaction Plate Medium 14 DePuy Synthes GYROS Mobile Bearing Cup Surgical Technique

ORDERING INFORMATION INSTRUMENTS L46714 Trial Cup GYROS Diam 44 L46716 Trial Cup GYROS Diam 46 L46718 Trial Cup GYROS Diam 48 L46720 Trial Cup GYROS Diam 50 L46722 Trial Cup GYROS Diam 52 L46724 Trial Cup GYROS Diam 54 L46726 Trial Cup GYROS Diam 56 L46728 Trial Cup GYROS Diam 58 L46730 Trial Cup GYROS Diam 60 L46732 Trial Cup GYROS Diam 62 L46734 Trial Cup GYROS Diam 64 L46736 Trial Cup GYROS Diam 66 L46738 Trial Cup GYROS Diam 68 L46844 Trial Insert GYROS 22.5/44 L46846 Trial Insert GYROS 22.5/46 L46848 Trial Insert GYROS 22.5/48 L46850 Trial Insert GYROS 22.5/50 L46852 Trial Insert GYROS 22.5/52 L46854 Trial Insert GYROS 22.5/54 L46856 Trial Insert GYROS 22.5/56 L46858 Trial Insert GYROS 22.5/58 L46860 Trial Insert GYROS 22.5/60 L46862 Trial Insert GYROS 22.5/62 L46864 Trial Insert GYROS 22.5/64 L46866 Trial Insert GYROS 22.5/66 L46868 Trial Insert GYROS 22.5/68 L46948 Trial Insert GYROS 28/48 L46950 Trial Insert GYROS 28/50 L46952 Trial Insert GYROS 28/52 L46954 Trial Insert GYROS 28/54 L46956 Trial Insert GYROS 28/56 L46958 Trial Insert GYROS 28/58 L46960 Trial Insert GYROS 28/60 L46962 Trial Insert GYROS 28/62 L46964 Trial Insert GYROS 28/64 L46966 Trial Insert GYROS 28/66 L46968 Trial Insert GYROS 28/68 GYROS Mobile Bearing Cup Surgical Technique DePuy Synthes 15

References 1. Philippot R, Camilleri JP, Boyer B, Adam P, Farizon F. The use of a dual-articulation acetabular cup system to prevent dislocation after primary total hip arthroplasty: analysis of 384 cases at a mean follow-up of 15 years. Int Orthop. 2009;33(4):927-32. Legal Manufacturer Implants Instruments DePuy France S.A.S. DePuy Orthopaedics, Inc. All GYROS implants X-ray template, Drill bit, Leg bender, Plate holder, Final cup impactor, Hook guide, Tip rim Impactor, Version Guide, Screw holder, Drill guide, Bronze ring, Trial cup impactor, Impactor shaft, Gun impactors, Trial cup, Trial insert. DURALOC impactor, Ratchet handle, Hexagonal screwdriver The third-party trademarks used herein are trademarks of their respective owners. DePuy Orthopaedics EMEA is a trading division of DePuy International Limited. Registered Office: St. Anthony s Road, Leeds LS11 8DT, England Registered in England No. 3319712 DePuy France S.A.S 7, allèe Joliot Curie 69800 Saint-Priest France Tel: +33 (0)4 72 79 27 27 Fax: +33 (0)4 72 79 28 28 0459 DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581-0988 USA Tel: +1 (800) 366 8143 Fax: +1 (574) 267 7196 DePuy International Ltd St Anthony s Road Leeds LS11 8DT England Tel: +44 (0)113 387 7800 Fax: +44 (0)113 387 7890 0086 depuysynthes.com DePuy International Ltd. and DePuy Orthopaedics, Inc. 2014. All rights reserved. CA#DPEM/ORT/1212/0408(1) 9080-96-100 Issued: 01/14