SMR AXIOMA TT METAL BACK SURGICAL TECHNIQUE

Transcription

1 SMR AXIOMA TT METAL BACK SURGICAL TECHNIQUE

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3 Index Indications, Contraindications and Warnings pag. >> 6 Introduction pag. >> 9 Clinical Cases pag. >> 13 SMR AXIOMA TT METAL BACK SURGICAL TECHNIQUE Foreword pag. >> 14 Glenoid Preparation pag. >> 15 Implantation pag. >> 19 SMR Anatomic pag. >> 22 SMR Reverse pag. >> 23 TT Metal Back Removal pag. >> 25 PRODUCT DIMENSIONS pag. >> 28 INSTRUMENT SET pag. >> 30 PRODUCT CODES pag. >> 36 Limacorporate spa, as manufacturer of prosthetic devices, does not practice medicine. This surgical technique brochure has been developed in consultation with an experienced surgeon team and provides the surgeon with general guidance when implanting SMR AXIOMA TT METAL BACK. Proper surgical procedures and techniques are necessarily the responsibility of the medical professional. Each surgeon must evaluate the appropriateness of the surgical technique used based on personal medical training, experience and clinical evaluation of each individual patient. For further information about our products, please visit our web site at LEONARDO DA VINCI: Vitruvian Man. Study of the proportions of the human body (1490). SMR AXIOMA TT METAL BACK Surgical Technique 3

4 SMR AXIOMA AXIOMA SMR The clinically proven SMR System evolves with the pathology, allowing the surgeon to choose the most appropriate solution in resurfacing, fracture replacement, total shoulder, reverse shoulder or revision surgeries 1,2,3,4,5,6,7. BIBLIOGRAPHY: [1] A. Castagna, M. Randelli, R. Garofalo, L. Maradei, A. Giardella, M. Borroni. Mid-Term results of a metalbacked glenoid component in total shoulder replacement. J Bone Joint Surg [Br], 92(10): , [2] A.Castagna, M. Delcogliano, F. de Caro, G. Ziveri, M. Borroni, S. Gumina, F. Postacchini, C.F. De Biase. Conversion of shoulder arthroplasty to reverse implants: clinical and radiological results using a modular system. Int Orthop. May [3] C.F. De Biase, M. Delcogliano, R.M. Polo, M. Borroni, A. Castagna. The use of an eccentric glenosphere in reverse total shoulder arthroplasty: two years minimum follow-up results. Bone Joint J. 2013;95-B(Suppl 15):157. [4] S.W. Young, N.M. Everts, C.M. Ball, T.M. Astley, P.C. Poon. The SMR reverse shoulder prosthesis in the treatment of cuffdefi cient shoulder conditions. J Shoulder Elbow Surg, 18(4): , [5] A.A. Martinez, A. Calvo, C. Bejarano, I. Carbonel, A. Herrera. The use of the Lima reverse shoulder arthroplasty for the treatment of fracture sequelae of the proximal humerus. J Orthop Sci, 17(2):141-7, 2012.

5 TT METAL BACK METAL BAC ACK TT Based on clinical heritage of the SMR System, Axioma TT Metal Back glenoid breaks new ground in glenoid replacement, combining unique implant design with the advanced Trabecular Titanium TM structure. The material, the structure, the mechanical properties and the enhanced initial fi xation, are the premises for signifi cantly greater primary fi xation followed by an improved biologic integration of the implants 8,9,10. [6] K. Mohammed, A. Slaven. Reliable osteointegration of a metal back glenoid in conventional total shoulder arthroplasty at minimum 3 years follow up. J Bone Joint Surg Br. 2012; 94-B (Supp XXI): [7] R. Postacchini, A. Castagna, M. Borroni, G. Cinotti, F. Postacchini, S. Gumina. Total shoulder arthroplasty for the treatment of failed hemiarthroplasty in patients with fracture of the proximal humerus. J Shoulder Elbow Surg Mar 3. [8] E. Marin, L. Fedrizzi, M. Regis, M. Pressacco, L. Zagra, S. Fusi. Stability enhancement of prosthetic implants: friction analysis of Trabecular Titanium TM. Hip International, 22(4): , [9] V. Sollazzo, A. Palmieri, L. Massari, F. Carinci. Genetic effects of Trabecular Titanium TM on cells MG-63 cell line: an in vitro study. J Orthpaed Traumatol., 13(1): 107, [10] H.R. Bloch, S. Burelli, D. Devine, D. Arens. Enhanced bone in-growth of the highly porous Trabecular Titanium. In Proceedings of 13th European Federation of National Association of Orthopaedics and Traumatology (EFORT), Berlin, Germany, May, 2012.

6 SMR SURGICAL TECHNIQUE Indications, Contraindications and Warnings Please follow the instructions for use enclosed in the product packaging. INDICATIONS The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; infl ammatory degenerative joint disease such as rheumatoid arthritis; treatment of acute fractures of the humeral head that cannot be treated with other fracture fi xation methods; revision of a failed primary implant; cuff tear arthropathy (CTA Heads only). The Large Resection Stems are indicated for oncology applications. The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff defi cient joint with severe arthropathy (disabling shoulder). The patient s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specifi ed in the following table. In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fi xation of the humeral stem determines if the construct is cemented or uncemented. The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid construct consists of the metal back, the connector and the glenosphere. On the glenoid side, the fi xation of the all polyethylene glenoid or the metal back determines if the construct is cemented or uncemented. 6 Surgical Technique SMR AXIOMA TT METAL BACK

7 SMR SURGICAL TECHNIQUE Indications, Contraindications and Warnings System Use Anatomic Reverse Components Material Cem. Not Cem. SMR Stems (Cemented, Cemented Revision) Ti6Al4V X SMR Stems (Cementless Finned, Cementless Revision) Ti6Al4V X SMR Large Resection stems Ti6Al4V X SMR Modular Augments Ti6Al4V X SMR Humeral Bodies (Trauma, Finned) Ti6Al4V X X SMR Reverse Humeral Body Ti6Al4V X X SMR Reverse HA Coated Humeral Body Ti6Al4V+HA X SMR Humeral Extension Ti6Al4V X X SMR Humeral Heads (Standard, CTA) CoCrMo X X Ti6Al4V X X SMR Adaptor Tapers (Neutral, Eccentric) Ti6Al4V X X SMR CTA Head Adaptor for Reverse Humeral Body Ti6Al4V X X SMR Glenospheres CoCrMo Ti6Al4V UHMWPE X-Lima +Ti6Al4V X X X SMR Connectors Ti6Al4V X UHMWPE X-Lima X X Reverse Liners CoCrMo X X Alumina X X SMR Cemented Glenoids UHMWPE X SMR 3 Pegs Cemented Glenoids UHMWPE X-Lima X SMR Metal Back Glenoids Ti6Al4V+PoroTi+HA X SMR TT Metal Back Baseplate Ti6Al4V X SMR TT Metal Back Peg Ti6Al4V X SMR Metal Back Liner UHMWPE X SMR Bone screws Ti6Al4V X SMR Glenoid Plates Ti X Material Standards Ti6Al4V (ISO ASTM F1472) - CoCrMo (ISO ASTM F1537) Ti (ASTM F67) - UHMWPE (ISO ASTM F648) Alumina (ISO 6474) PoroTi Titanium Coating (ASTM F1580) HA Hyroxyapatite Coating (ISO 13779) SMR AXIOMA TT METAL BACK Surgical Technique 7

8 SMR SURGICAL TECHNIQUE Indications, Contraindications and Warnings WARNINGS In selecting patients for surgery, the following factors can be critical to the success of the procedure: Partial Shoulder Replacement: In cases with a defi cient and unreconstructable rotator cuff, a CTA-head is indicated. Total Shoulder Replacement: The rotator cuff must be intact or reconstructable. In cases with a defi cient and unreconstructable rotator cuff, a hemiprosthesis with a CTA head or a Reverse Total Shoulder Arthroplasty is indicated. Reverse Shoulder Replacement: The bone stock of the glenoid and humerus must be able to support the implant. In cases with signifi cant bone loss and in which adequate fi xation on the glenoid side cannot be obtained, a hemiarthroplasty with a CTA-head should be performed. Note. With CTA Heads the use of Trauma Humeral Bodies is recommended to avoid possible impingement between the head and the body when using the Finned Humeral Body. Note. The metal back size is Large is not suitable for coupling with 36 mm and 40 mm glenospheres. CONTRAINDICATIONS Absolute contraindications include: local or systemic infection; septicaemia; persistent acute or chronic osteomyelitis; confi rmed nerve lesion compromising shoulder joint function; deltoid muscle insuffi ciency. Relative contraindications include: vascular or nerve diseases affecting the concerned limb poor bone stock (for example due to osteoporosis or extended previous revision surgery) compromising the stability of the implant; metabolic disorders which may impair fi xation and stability of the implant; any concomitant disease and dependence that might affect the implanted prosthesis; metal hypersensitivity to implant materials. In cases of bone tumors, use an appropriate system designed to treat cases requiring large bone resections (SMR Large Resections Stems). The use of primary or revision implants not designed and intended for use in cases of bone resection may result in a poor outcome and / or failure of the implant or implant fi xation. RISK FACTORS The following risk factors may result in poor results with this prosthesis: overweight; strenuous physical activities (active sports, heavy physical work); fretting of modular junctions; incorrect implant positioning; muscle defi ciencies; multiple joint disabilities; refusal to modify postoperative physical activities; patient history of infections or falls; systemic diseases and metabolic disorders; local or disseminated neoplastic diseases drug therapies that adversely affect bone quality, healing, or resistance to infection drug use or alcoholism; marked osteoporosis or osteomalacia; patient s resistance to disease generally weakened (HIV, tumour, infections); severe deformity leading to impaired anchorage or improper positioning of implants; osteolysis. 8 Surgical Technique SMR AXIOMA TT METAL BACK

9 SMR SURGICAL TECHNIQUE Introduction PREOPERATIVE PLANNING Standard X-rays are used to assist with planning of the operation. It is recommended to use a normal AP-view in internal and external rotation as well as an axillary view, Bernageau or Morrison view. It is recommended to use a CT-Scan in fractures cases and for planning the glenoid insertion. If required an MRI can be used for clear examination of the extent of the bone defi ciency and to see the muscle/ capsule quality. In post-traumatic cases, such as in special cases of disabling shoulder, a neurological exam is helpful for decision making. Templates are used in all osteoarthritic cases; they can also be used in fracture cases but often in a limited mode, depending on the type of fracture. The X-ray templates provided for SMR have a 105% scale; digital templates are available as well. ANAESTHESIA Shoulder surgery is one of the areas in which an understanding of the surgery and participation by the anaesthesiologist is especially important for the outcome of the surgery. This applies to accurate preoperative evaluation of the patient as well as intra op techniques. They should have a good understanding of positioning on the operating table and postoperative pain management. be accurately followed by the anaesthetic staff to avoid hypotension and consecutive brain hypoperfusion. Postoperative analgesia is important and can be performed by intravenous, single injection or on demand application of analgesics. Patient-controlled analgesia (PCA) is recommended. POSITIONING Shoulder arthroplasty is normally performed in a beachchair position; the surgeon needs complete access to the shoulder joint. The arm is free or stabilized by arm-holders. The shoulder must be positioned off the edge of the table to afford unobstructed arm extension. The patient s head must be supported and stabilized in the neutral position. Nerve injury due to brachial plexus traction during positioning and surgery must be avoided. If possible, one assistant should stay behind the shoulder, the second on the opposite side of the patient, so that the surgeon has a complete anterior view of the shoulder and can move the joint without any obstacle. Shoulder prosthetic replacement can be performed with regional (scalenus) anaesthesia combined with sedation and/or with general anaesthesia. The modern technique of interscalenic block was introduced by Winnie in 1970 and soon became the standard for anaesthesia and postoperative pain management in shoulder surgery. Requested surgical positioning (beach chair position) must SMR AXIOMA TT METAL BACK Surgical Technique 9

10 Introduction ACCESS We recommend two types of surgical approaches to the shoulder joint. As in every surgical procedure, the access depends not only on diagnosis and planned surgical treatment but also on the experience of the surgeon. Ranges of glenohumeral motion are evaluated with the patient under anaesthesia to confi rm the preoperative assessment and the extent of capsular release needed to restore the ROM postoperatively. DELTO-PECTORAL APPROACH With the clavipectoral fascia incised, a retractor can easily be placed over the superolateral aspect of the humeral head to retract the deltoid. The conjoined tendon is retracted medially. The musculocutaneous nerve penetrates the lateral coracobrachialis muscle 3 to 8 cm distally of the tip of the coracoid process. The position of the axillary nerve should be indentified along the anterior surface of the subscapularis muscle, below the conjoined tendon. The axillary nerve crosses the inferolateral border of the subscapularis 3 to 5 mm medially of its musculotendinous junction and has an intimate anatomic relation with the inferior capsule of the shoulder joint. The anterior humeral circumflex artery and veins are visualized, ligated and divided. The subscapularis tendon is released, divided 1 cm medially to its attachment or with some bone chip of the lesser tuberosity. Separation of the subscapularis from the capsule and incision of the capsule is performed to the inferior border of the glenoid rim, protecting the axillary nerve with a blunt retractor. Release of the subscapularis and 360 capsular release. Closure: In fracture cases, accurate reconstruction of the minor and major tubercles by suture, bone anchors or cerclage is mandatory. If the long head of the biceps tendon is intact, reconstruct also the biceps groove to avoid impingement. Closure of delto-pectoral groove. Anterior vertical incision, starting 1 cm laterally of the coracoid bone, slanting towards the axillary s pouch. If there is a metaphysal fracture, slanting laterally towards the deltoid insertion at the humerus. The cephalic vein is retracted laterally with the deltoid muscle.the clavipectoral fascia is incised along the lateral edge of the conjoined tendon up to the coracoacromial ligament. 10 Surgical Technique SMR AXIOMA TT METAL BACK

11 Introduction LATERAL (DELTOID SPLITTING) APPROACH Begin the incision at the anterolateral tip of the acromion and carry it distally over the deltoid muscle about 5 cm. Defi ne the tendinous interval on 4 to 5 cm between the anterior and middle thirds of the deltoid; splitting the muscle here provides an avascular approach to underlying structures. Incise the thin wall of the subdeltoid bursa and explore the rotator cuff as desired by rotating and abducting the arm to bring different parts of it into view. SMR AXIOMA TT METAL BACK Surgical Technique 11

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13 Clinical Cases CASE I GENDER: female AGE: 74 years old PATHOLOGY: arthritis PRIMARY IMPLANT: total anatomic REASON FOR REVISION: aseptic loosening of cemented glenoid, pain Pre-operative Post-operative CASE II GENDER: male AGE: 76 years old PATHOLOGY: concentric arthritis PRIMARY IMPLANT: hemiarthroplasty REASON FOR REVISION: eroded glenoid, pain Pre-operative Post-operative SMR AXIOMA TT METAL BACK Surgical Technique 13

14 Foreword FOREWORD The technique described in this section deals with the use of SMR Axioma TT Metal Back glenoid component related to a primary implant with consistent bone deficiency or poor bone quality or revision that has lead to a consistent bone loss. In this latter case, the described steps presume the prior removal of the existing implant. Revision surgery begins with a vigilant attention for preservation of existing glenoid bone stock. The surgeon must exercise meticulous care when removing the glenoid component and, if present, the cement mantle from the native glenoid. The implant is suitable for implantation on the glenoid with or without bone graft. If the preoperative planning indicates that the glenoid bone stock is insufficient to support the implant, due to either poor quality of bone or insufficient bone stock, a variety of bone grafting techniques can be employed. The bone graft dimensions are related to the glenoid deficiency in order to restore the correct glenoid version and the natural positioning of the articular surface. The lateralization of the final implant can be adapted to specific needs thanks to the modularity of the SMR Axioma TT Metal Back. The natural glenoid bone augmented by the bone graft must be remodelled in such a way that the definitive SMR Axioma TT Metal Back implant seats congruently on the bone surface. Each surgeon must evaluate the adeguacy of the surgical technique used, based on personal training, experience and clinical evaluation of each individual patient. 14 Surgical Technique SMR AXIOMA TT METAL BACK

15 Glenoid Preparation Figure 1 EXPOSURE OF THE GLENOID Expose the glenoid with suitable retractors. The Fukuda retractor keeps the proximal portion of the humerus outside of the joint area, while maintaining optimal exposure of the glenoid surface. Generally, the retractor is anchored to the rear of the glenoid neck rim in a deltopectoral approach, or on the lower rim in a supero-lateral approach. DETERMINATION OF THE GLENOID CENTRE In primary implant, after having completely exposed the glenoid, trace two orthogonal lines along the main axes using an electric scalpel (Figure 1). This operation does not require any particular measurement as its only purpose is to determine more or less the centre of the glenoid and to avoid errors when positioning the implant. SMR AXIOMA TT METAL BACK Surgical Technique 15

16 Glenoid Preparation Figure 2 Figure 3 INSERTION OF THE GUIDE WIRE PREPARATION OF GLENOID SURFACE For the glenoid preparation use a 15 cm long and 2.5 mm dia. guide wire (not included in the instrument set) and insert it into the bone (Figure 2). The direction taken by the guidewire will determine the final version of the glenoid component (Axioma TT Metal Back). Therefore, perform a CT beforehand to evaluate any deformations in the articular surface caused by degenerative pathologies or traumata. All corrections should be made at this stage as no corrections can be made when impacting the implant. Glenoid reaming is performed to achieve intimate contact between the bone and the spherical undersurface of the glenoid implant and to establish appropriate glenoid version. Once the Kirschner wire has been fixed, slide the SMALL or STD glenoid reamer (G3) over it, depending on the glenoid dimensions. Apply the glenoid reamer shaft (H3) and ream the bone surface (Figure 3). The purpose of this operation is to remove the cartilage and expose the subchondral bone. 16 Surgical Technique SMR AXIOMA TT METAL BACK

17 Glenoid Preparation Figure 4 Figure 5 DRILLING FOR THE CENTRAL HOLE Remove the reamer and prepare the central hole. Attach the SMALL-R SHORT (B35) reamer on the glenoid reamer shaft (A35) (Figure 4) and drill on the guide wire, until the reamer baseplate touches the subchondral bone. If a component with longer peg is required, use the size SMALL-R MEDIUM/LONG or X-LONG (B35) reamer to prepare the central hole (Figure 5). If a component with larger peg is required (for TT Metal Back SMALL or STD) use the SHORT, MEDIUM, LONG or X-LONG reamers. SMR AXIOMA TT METAL BACK Surgical Technique 17

18 Glenoid Preparation Figure 6 Figure 7 Figure 8 In case of compaction grafting, proceed as described in the previous section. Connect the compactor handle (C35) to the compactor (D35) of the same size as the last peg reamer used (Figure 6). The compactors are used to compact the bone chips previously inserted into the glenoid cavity and verify the right size of the Axioma TT Metal Back. Insert the cannulated compactor in the glenoid cavity using the K-wire as a guide (Figure 7) and ensure it seats flush on the reamed glenoid (Figure 8). 18 Surgical Technique SMR AXIOMA TT METAL BACK

19 Implantation Figure 9 Figure 10 ASSEMBLE FINAL PEG AND BASEPLATE Remove the Axioma TT Metal Back baseplate and peg of the chosen size from the sterile packaging. Warning. Peg size must match the baseplate size as described in the warning label on the packaging. Apply the peg to the baseplate (Figure 9) and secure the connections using the TT Metal Back press (H35) and the torque wrench (I35) (Figure 10). Turn clockwise the torque wrench to achieve one click to confirm the proper tightening. Do not exceed recommended torque as excessive tightening may damage the instrument or implant. SMR AXIOMA TT METAL BACK Surgical Technique 19

20 Implantation Figure 11 Figure 12 Figure 13 Figure 14 INSERTION OF FINAL TT METAL BACK Screw the appropriate impactor guide (F35) (SMALL-R or SMALL/STD) to the final implant and apply the impactor (E35) (Figures 11-12). In case bone grafting is used between the Axioma TT Metal Back and native bone, the surgical steps described should be performed on the graft in order to prepare the seat (baseplate curvature and dimensions of the central hole) of the final implant. Insert the glenoid prosthesis into the prepared glenoid by tapping it in with the impactor handle until there is complete contact with the glenoid surface. The long axis of the prosthesis should coincide with the larger axis of the glenoid (Figures 13-14). Remove the impactor by pressing the release button and unscrew the impactor guide from the implanted Axioma TT Metal Back. Insert the assembled final implant into the prepared bone graft using the glenoid impactor. The glenoid cavity should be prepared according to the glenoid defect dimensions and final insertion of the definitive peg. Finally insert the Axioma TT Metal Back with the bone graft into the glenoid cavity using the impactor and proceed with the following steps of the surgical technique. 20 Surgical Technique SMR AXIOMA TT METAL BACK

21 Implantation Figure 15 Figure 16 INSERTION OF BONE SCREWS Once the Axioma TT Metal Back glenoid has been positioned, drill the sites for the fixation screws using the flexible mandrel (K3) with a 3.5 mm helix drill bit (M3) inserted on the drill guide (I3) (Figure 15). The screwhead seat on the metal shell is spherical and therefore the fitting direction can be chosen within an angular range of +/-15. After having prepared the seating of the first screw, insert the screw using the screwdriver (L3) but do not fully tighten until the next screw hole has been prepared and another screw has been inserted (Figure 16). The screws must be tightened at the same time to guarantee the best fit of the metal glenoid into the prepared bone seat. Nevertheless, the superior screw is recommended to be directioned to the base of the coracoid, while the inferior screw should point dorsally. SMR AXIOMA TT METAL BACK Surgical Technique 21

22 SMR Anatomic Figure 17 Figure 18 Once the Axioma TT Metal Back has been inserted, including the screws, the choice of using a reverse or an anatomic prosthesis can be made thanks to the implant modularity. Both cases are described in the present document: SMR Anatomic at page 22 and SMR Reverse at page 23. SMR ANATOMIC ANATOMIC LINER INSERTION Warning. In the Anatomic configuration the Axioma TT Metal Back is intended for coupling only with the liner X0. Remove the polyethylene liner of the same size as the Axioma TT Metal Back from the sterile packaging and after having carefully cleaned the inside and the edges of the Axioma TT Metal Back from fat and soft tissue, push by hand the liner until it snaps in (Figures 17-18). Note. Insertion is not reversible. If the liner has already been inserted and needs to be removed, open another liner packaging of the same size and reinsert the new liner after the removal of the previous one. During the next steps, be aware not to damage the liner with metal objects. 22 Surgical Technique SMR AXIOMA TT METAL BACK

23 SMR Reverse Figure 19 SMR REVERSE INSERTION OF THE TRIAL GLENOSPHERE Apply the trial glenosphere (36 mm, 40 mm or 44 mm diameter) and position it on the implanted glenoid TT Metal Back. The trial glenosphere screw (R4 or P4) is inserted through the central hole using the screwdriver (Figure 19). In case of eccentric trial glenosphere the surgeon can rotate the glenosphere on the Metal Back until the most stable position for the new joint has been obtained. Note the last position used for the eccentric glenosphere and trace a reference point in order to reproduce the correct position with the final implant. Note. The 36 mm glenopspheres are not suitable for coupling with the glenoid plates XX. SMR AXIOMA TT METAL BACK Surgical Technique 23

24 SMR Reverse Figure 20 Figure 21 INSERTION OF THE FINAL IMPLANT FINAL IMPLANT REDUCTION Remove the trial glenosphere using the screwdriver. Take the final glenosphere (36 mm, 40 mm or 44 mm diameter), peg and safety screw of the correct size. Insert the peg into the appropriate taper on the glenosphere and secure the components by tapping. Screw the glenosphere impactor-extractor (T4) into the glenosphere hole and impact the assembly into the Axioma TT Metal Back (Figure 20). Unscrew the impactor and check by hand that the Morse taper is stable. Tighten the safety screw (Figure 21). If using 40 mm or 44 mm glenospheres, press-fit the cap in the central hole of the implant using the positioner for glenosphere plug (G42). Refer to SMR Primary Surgical Technique for preparation of the humerus. Reduce the joint and carry out a final assessment of joint stability and range of motion. Palpating the axillary nerve should find a normal structure tension as before surgery. 24 Surgical Technique SMR AXIOMA TT METAL BACK

25 TT Metal Back Removal Figure 22 Should it become necessary to remove the Axioma TT Metal Back implant, the instrument set should be used. In case of reverse implant the instrument set is necessary in addition. Do not re-use the implant once it has been removed. REVERSE IMPLANT REMOVAL OF GLENOSPHERE (36 mm, 40 mm or 44 mm) By means of screwdriver (L3), remove the safety screw of the glenosphere. ANATOMIC IMPLANT COMPONENT REMOVAL This operation should be made smoothly to avoid excessive torsion on the glenoid and/or screw damage. REMOVAL OF THE LINER In the anatomic configuration, remove the polyethylene liner by inserting a small osteotome between the liner and the Axioma TT Metal Back glenoid. Screw the glenosphere impactor-extractor (T4) on the previously implanted glenosphere and disassemble it from the SMR Axioma TT Metal Back with the help of the manual snap wrench (V4) (Figure 22). SMR AXIOMA TT METAL BACK Surgical Technique 25

26 TT Metal Back Removal Figure 23 Figure 24 REMOVAL OF THE TT METAL BACK BASEPLATE In order to disconnect the baseplate from the peg, select the baseplate extractor (J35) SMALL-R or standard according to the SMR Axioma TT Metal Back size (Figure 23) and insert it into the implanted baseplate until the extractor lock into the baseplate grove. Disassemble the baseplate by rotating the T-handle clockwise and using the multipurpose handle as a counter torque (Figure 24). This will help to prevent torsion on the glenoid. The baseplate will disconnect from the peg leaving the peg in situ. 26 Surgical Technique SMR AXIOMA TT METAL BACK

27 TT Metal Back Removal Figure 25 Figure 26 Figure 27 REMOVAL OF THE TT METAL BACK PEG Select the cannulated reamer (SMALL-R or standard) according to the peg size (Figure 25) and adjust its internal bar according to the peg length (SHORT, MEDIUM, LONG or X-LONG). The bar has a mobile plastic part with the etchings of the four lengths. Take care to position the bar in the correct position related to the peg size as this will determine the progression of the cannulated reamer (L35) (Figure 26). Screw the internal bar of the cannulated reamer onto the implanted peg and afterwards use the cannulated reamer to remove the peg (Figure 27). SMR AXIOMA TT METAL BACK Surgical Technique 27

28 Product Dimensions SMR AXIOMA TT METAL BACK PEG Ø P Ø D Length Size Small-R Small/STD Ø Proximally Ø Distally Length Ø Proximally Ø Distally Length (mm) (mm) (mm) (mm) (mm) (mm) Short Medium Long X-Long Surgical Technique SMR AXIOMA TT METAL BACK

29 Product Dimensions SMR AXIOMA TT METAL BACK BASEPLATE Superior-Inferior Anterior-Posterior Size Superior-Inferior (mm) Anterior-Posterior (mm) Small-R Small Standard SMR AXIOMA TT METAL BACK LINER Superior-Inferior Anterior-Posterior Size Superior-Inferior Anterior-Posterior Radius of curvature (mm) (mm) (mm) Small-R Small Standard SMR AXIOMA TT METAL BACK Surgical Technique 29

30 Instrument Set Common Instrument Set for SMR Shoulder Prosthesis Ref. CODE DESCRIPTION Qty. A Reamer 1 B Conical Trial Stem Dia B Conical Trial Stem Dia B Conical Trial Stem Dia B Conical Trial Stem Dia B Conical Trial Stem Dia B Conical Trial Stem Dia B Conical Trial Stem Dia B Conical Trial Stem Dia B Conical Trial Stem Dia B Conical Trial Stem Dia B Conical Trial Stem Dia C Stem Impactor 2 D Manual Snap Wrench Sterilizable Box 1 30 Surgical Technique SMR AXIOMA TT METAL BACK

31 Instrument Set Endoprosthesis Instrument Set for SMR Shoulder Prosthesis Ref. CODE DESCRIPTION Qty. A Prosthesis Introducer 1 B Wrench for Knurled Stems 1 C Trial Humeral Head Dia. 42 mm 1 C Trial Humeral Head Dia. 44 mm 1 C Trial Humeral Head Dia. 46 mm 1 C Trial Humeral Head Dia. 48 mm 1 C Trial Humeral Head Dia. 50 mm 1 C Trial Humeral Head Dia. 52 mm 1 C Trial Humeral Head Dia. 54 mm 1 D Head Gauge 1 E Trial Neutral Adaptor STD 1 E Trial Ecc. 2 mm Adaptor STD 1 E Trial Ecc. 4 mm Adaptor STD 1 E Trial Ecc. 8 mm Adaptor STD 1 E Trial Neutral Adaptor Long 1 E Trial Ecc. 2 mm Adaptor Long 1 E Trial Ecc. 4 mm Adaptor Long 1 E Trial Ecc. 8 mm Adaptor Long 1 F Pliers for Trial Adaptor 1 G Trial Humeral Body Medium 1 G Trial Humeral Body Long 1 G Trial Humeral Body Short 1 H Body Stopper 1 I Head Extractor 1 J Extractor for Humeral Body 1 K Universal Stem for Extractor 1 L Allen Wrench 1 M Stop Guide 1 N Right Resection Mask 1 N Left Resection Mask 1 O Alignment Rod 1 P Expansion Extractor 1 Q Humeral Head Impactor 1 R Humeral Head Press 1 S Centimeter Sterilizable Box 1 SMR AXIOMA TT METAL BACK Surgical Technique 31

32 Instrument Set Glenoid Instrument Set for SMR Shoulder Prosthesis Ref. CODE DESCRIPTION Qty. A Extractor for SMALL-R M-B Glenoid 1 A Extractor for M-B Glenoid 1 B Humeral Cover 1 C SMALL-R M-B Glenoid Impactor 1 C SMALL/STD/LARGE M-B Glenoid Impactor 1 D SMALL-R Glenoid Drill 1 D Glenoid Drill 1 E Cemented Glenoid Impactor 1 F Fukuda Retractor 1 G Glenoid Reamer - SMALL 1 G Glenoid Reamer - STD 1 H Glenoid Reamers Shaft 1 I Drill Guide 1 J Pliers for Screws 1 K Flexible Mandrel 1 L Screwdriver 1 M Helix Drill - Dia. 3.5 x 50 mm Sterilizable Box 1 32 Surgical Technique SMR AXIOMA TT METAL BACK

33 Instrument Set TT Metal Back Set Ref. CODE DESCRIPTION Qty. A Glenoid reamer shaft 1 B SMALL-R SHORT Reamer 1 B SMALL-R MEDIUM Reamer 1 B SMALL-R LONG Reamer 1 B SMALL-R X-LONG Reamer 1 B SHORT Reamer 1 B MEDIUM Reamer 1 B LONG Reamer 1 B X-LONG Reamer 1 C Compactor handle 1 D SMALL-R SHORT Compactor 1 D SMALL-R MEDIUM Compactor 1 D SMALL-R LONG Compactor 1 D SMALL-R X-LONG Compactor 1 D SHORT Compactor 1 D MEDIUM Compactor 1 D LONG Compactor 1 D X-LONG Compactor 1 E Impactor 1 F SMALL-R Impactor Guide 1 F Impactor Guide 1 G T handle with Zimmer connection 1 H TT Metal Back press 1 I Torque wrench 1 J SMALL-R Baseplate extractor 1 J Baseplate extractor 1 K Multipurpose handle 1 L SMALL-R Cannulated Reamer 1 L Cannulated Reamer Sterilizable Box 1 SMR AXIOMA TT METAL BACK Surgical Technique 33

34 Instrument Set Reverse Instrument Set for SMR Shoulder Prosthesis Ref. CODE DESCRIPTION Qty. A Screw for Humeral Body 2 B Head Extractor 1 C Extractor for Humeral Body 1 D Universal Stem for Extractor 1 E Allen Wrench 1 F Alignment Rod 1 G Trial Extension for Humeral Reverse Body H Trial Reverse Humeral Body 1 I Resection Mask for Reverse Prosth. 1 J Guide for Conical Reamer 1 K Conical Reamer 1 L Humeral Body Impactor 1 M Expansion Extractor 1 N Stop Guide 1 O STD Trial Liner 1 O Trial Liner 1 O Trial Liner 1 P Guide Screw SMALL-R Trial Glenosphere 2 Q Trial Glenosphere Dia. 36 mm 1 R Guide-Screw for Trial Glenosphere 2 S T Driver for Trial Glenosphere 1 T Glenosphere Impactor-Extractor 1 U Trial Ecc. Glenosphere Dia. 36 mm 1 V Manual Snap Wrench Sterilizable Box Surgical Technique SMR AXIOMA TT METAL BACK

35 Instrument Set SMR Reverse HP Set Ref. CODE DESCRIPTION Qty. A Trial Liner SHORT Dia. 44 mm 1 A Trial Liner MEDIUM Dia. 44 mm 1 A Trial Liner LONG Dia. 44 mm 1 A Trial Liner Lateralizing MEDIUM Dia. 44 mm 1 A Trial Liner Lateralizing LONG Dia. 44 mm 1 B Trial Liner SHORT Dia. 40 mm 1 B Trial Liner MEDIUM Dia. 40 mm 1 B Trial Liner LONG Dia. 40 mm 1 B Trial Liner Lateralizing MEDIUM Dia. 40 mm 1 B Trial Liner Lateralizing LONG Dia. 40 mm 1 C Guide-Screw SMALL-R Trial Glenosphere 2 D Guide-Screw Trial Glenosphere 2 E Trial Glenosphere Dia. 40 mm 1 F Trial Glenosphere Dia. 44 mm 1 F Trial Glenosphere Dia. 44 mm Corrective 1 G Positioner for Glenosphere Plug 1 H Trial Glenosphere Positioner Sterilizable Box 1 SMR AXIOMA TT METAL BACK Surgical Technique 35

36 Product Codes FINNED HUMERAL BODY WITH LOCKING SCREW Ti6Al4V Finned Humeral Body TRAUMA HUMERAL BODIES WITH LOCKING SCREW Ti6Al4V Medium Long Short CEMENTED STEMS L. 80 mm Ti6Al4V Dia. 12 mm Dia. 14 mm Dia. 16 mm Dia. 18 mm Dia. 20 mm CEMENTLESS MINI STEMS L. 60 mm Ti6Al4V Dia. 11 mm Dia. 12 mm Dia. 13 mm CEMENTLESS FINNED STEMS L. 80 mm Ti6Al4V Dia. 14 mm Dia. 15 mm Dia. 16 mm Dia. 17 mm Dia. 18 mm Dia. 19 mm Dia. 20 mm Dia. 21 mm Dia. 22 mm Dia. 23 mm Dia. 24 mm Upon Request 36 Surgical Technique SMR AXIOMA TT METAL BACK

37 Product Codes LARGE RESECTION STEMS Ti6Al4V Dia. 7 mm, h 50 mm Dia. 7 mm, h 80 mm Dia. 10 mm, h 50 mm Dia. 10 mm, h 80 mm MODULAR AUGMENTS Ti6Al4V h 20 mm h 30 mm h 40 mm h 50 mm RING Ti6Al4V Ring CEMENTED REVISION STEMS Ti6Al4V Dia. 13 mm - h 150 mm Dia. 13 mm - h 180 mm Dia. 13 mm - h 210 mm Dia. 15 mm - h 150 mm Dia. 15 mm - h 180 mm Dia. 15 mm - h 210 mm Upon Request SMR AXIOMA TT METAL BACK Surgical Technique 37

38 Product Codes CEMENTLESS REVISION STEMS Ti6Al4V Dia. 13 mm - h 150 mm Dia. 13 mm - h 180 mm Dia. 14 mm - h 150 mm Dia. 14 mm - h 180 mm Dia. 15 mm - h 150 mm Dia. 15 mm - h 180 mm Dia. 16 mm - h 150 mm Dia. 16 mm - h 180 mm NEUTRAL ADAPTOR TAPERS Ti6Al4V mm, Standard mm, Long ECCENTRICAL ADAPTOR TAPERS Ti6Al4V STANDARD mm mm mm LONG mm mm mm HUMERAL HEADS CoCrMo Dia. 40 mm Dia. 42 mm Dia. 44 mm Dia. 46 mm Dia. 48 mm Dia. 50 mm Dia. 52 mm Dia. 54 mm Upon Request 38 Surgical Technique SMR AXIOMA TT METAL BACK

39 Product Codes HUMERAL HEADS Ti6Al4V Dia. 42 mm Dia. 44 mm Dia. 46 mm Dia. 48 mm Dia. 50 mm Dia. 52 mm Dia. 54 mm CTA HUMERAL HEADS CoCrMo Dia. 42 mm Dia. 46 mm Dia. 50 mm Dia. 54 mm CTA HEADS ADAPTOR FOR REVERSE HUMERAL BODY Ti6Al4V Adaptor 36 mm for Reverse Humeral Body REVERSE HUMERAL BODIES WITH LOCKING SCREW Ti6Al4V HA Coated Reverse Humeral Body Short Reverse Humeral Body only for inversion Finned Reverse Humeral Body for Trauma Humeral Extension +9 mm Upon Request SMR AXIOMA TT METAL BACK Surgical Technique 39

40 Product Codes REVERSE LINERS 36 mm UHMWPE X-LIMA Standard mm mm Retentive Std Retentive +3 mm Retentive +6 mm GLENOSPHERE 36 mm WITH CONNECTOR CoCrMo Glenosphere - Small-R Glenosphere Eccentrical Glenosphere - Small-R Eccentrical Glenosphere GLENOSPHERE 36 mm WITH CONNECTOR Ti6Al4V Glenosphere - Small-R Glenosphere Eccentrical Glenosphere - Small-R Eccentrical Glenosphere Upon Request 40 Surgical Technique SMR AXIOMA TT METAL BACK

41 Product Codes REVERSE HP LINERS CoCrMo 40 mm Short Medium Long Lateralizing Liner - Medium Lateralizing Liner - Long 44 mm Short Medium Long Lateralizing Liner - Medium Lateralizing Liner - Long REVERSE CERAMIC LINERS 44 mm Alumina Medium Long REVERSE HP GLENOSPHERES UHMWPE X-LIMA + Ti6Al4V 40 mm Glenosphere 44 mm Glenosphere Corrective Glenosphere CONNECTORS WITH SCREW * Ti6Al4V Small-R Small STD * Necessary with REVERSE HP, optional with 36 mm glenospheres Upon Request SMR AXIOMA TT METAL BACK Surgical Technique 41

42 Product Codes CEMENTED GLENOIDS UHMWPE Small-R Standard Small CEMENTED GLENOIDS 3 PEGS UHMWPE Standard X-LIMA Small METAL BACK GLENOIDS L1 Ti6Al4V + PoroTi + HA Small-R Standard Small Large LINERS FOR METAL BACK GLENOIDS L1 UHMWPE Small-R Standard Small Large Upon Request 42 Surgical Technique SMR AXIOMA TT METAL BACK

43 Product Codes AXIOMA TT METAL BACKS Ti6Al4V Baseplate Small-R Baseplate Small Baseplate Standard Peg S-R Short Peg S-R Medium Peg S-R Long Peg S-R X-Long Peg S/STD Short Peg S/STD Medium Peg S/STD Long Peg S/STD X-Long LINERS FOR AXIOMA METAL BACK GLENOIDS UHMWPE Small-R Small Standard Large BONE SCREWS Ti6Al4V DIA. 6.5 mm L. 20 mm L. 25 mm L. 30 mm L. 35 mm L. 40 mm Upon Request SMR AXIOMA TT METAL BACK Surgical Technique 43

44 Product Codes GLENOID PLATES * Ti CP Small-R - Double Small STD - Double * Glenoid Plates are suitable for REVERSE HP only CORTICAL BONE SCREWS Ti6Al4V DIA. 4.5 mm L. 32 mm L. 36 mm L. 40 mm L. 44 mm L. 48 mm L. 52 mm Upon Request 44 Surgical Technique SMR AXIOMA TT METAL BACK

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