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This publication is not intended for distribution in the USA. Extraction of a CORAIL Stem Surgical Technique

Introduction Given the excellent long-term results of the CORAIL stem, 1,2,3 its extraction is a rare occurrence. The surgical technique described in this brochure at first considers two minimally invasive methods before describing a large osteotomy to extract a well osteointegrated CORAIL. The decision to go from one step to the next one is a clinical decision to be taken during the procedure. There are no established parameters; however the overall length of the operation should be taken into account. Our minimal invasive extraction technique uses specific instruments and a strategy that significantly reduces the operating time, in the great majority of the cases. This instrumentation can be used with any surgical approach. Several parameters must be carefully evaluated during the pre-operative templating of the new implant: type and size of the CORAIL stem that is being revised length of the stem to select the appropriate blades femoral morphology (cortical thickness, contact with implant, bone quality) planning of the extent of an eventual osteotomy selection of the implant for the reconstruction Following pre-revision templating, the necessary implants and instruments to deal with a range of possible intraoperative scenarios should be available to the surgeon during the procedure. ARTRO Group CORAIL design surgeon team Clinique d Argonay, France CORAIL Hip System Extraction of a CORAIL Stem Surgical Technique DePuy Synthes 1

First strategy : Minimally invasive extraction technique Releasing of the lateral shoulder of the stem The objective is to break the bony bridges between the cancellous bone and the lateral shoulder of the stem. This is achieved by repeatedly inserting and removing the osteotomes (Figures 1 and 2). If needed, the greater trochanter can be gouged to allow the blade to enter as lateral as possible to release this side of the stem (Figure 3). Figure 1 Figure 2 Figure 3 Releasing of the metaphysis area In case of the extraction of a collarless stem, introduce osteotomes at the level of the calcar (Figures 4 and 5). In case of the extraction of a collared stem, it may be necessary to carry out a horseshoe-shaped resection of 5-10 mm at the height of the calcar under the collar to allow the introduction of the osteotomes under the collar (Figure 6). Figure 4 Figure 5 Figure 6 2 CORAIL Hip System Extraction of a CORAIL Stem Surgical Technique DePuy Synthes

Introduce osteotomes along the anterior and posterior faces of the stem (Figures 7 and 8). The horizontal macro-structures on the stem help to guide them. Figure 7 Figure 8 Releasing of the diaphysis area The distal part of the stem, can be released using serrated Kirchner pins (1.8 mm diameter) fitted to a power source. It is important to check the length of the stem from the X-rays before starting this part of the procedure (Figures 9 and 10). The passage of the pins is guided by the vertical grooves of the stem. Figure 9 Figure 10 CORAIL Hip System Extraction of a CORAIL Stem Surgical Technique DePuy Synthes 3

Extraction using a slap hammer The extractor handle, the slap hammer and the threaded adapter are assembled and the adapter is screwed tightly to the stem. The slap hammer is used repeatedly in order to disrupt the implant/bone interface (bone bridge) (Figure 11). Note: Care must be taken to avoid any lateral movements (anterior-posterior or medial-lateral) since this could lead to fracture of the threaded adaptor. If the stem can be removed in this way (Figure 12), a CORAIL stem of an identical or a larger size than the removed one, a longer CORAIL stem or another indicated revision stem can be used to replace it. Figure 11 Figure 12 4 CORAIL Hip System Extraction of a CORAIL Stem Surgical Technique DePuy Synthes

Second strategy : Extraction of the stem by Longitudinal femoral osteotomy This strategy consists of splitting the femur for the extraction of the stem. From the X-rays, define the location of the tip of the stem. To augment this, align the same implant size broach with the femur (use as a template). Drill a hole at this level through both cortices using a 1.8 mm Kirchner drill to avoid propagation of the split (Figure 13). The osteotomy is then made running the oscillating saw distally to the drilled hole (Figure 14). The osteotomy is enlarged to open the femoral canal (Figure 15). Figure 13 Figure 14 Figure 15 CORAIL Hip System Extraction of a CORAIL Stem Surgical Technique DePuy Synthes 5

As described in the first strategy, try to extract the stem. If the stem can be removed (Figure 16), implant either a CORAIL of a larger or identical size to the one removed, a CORAIL revision stem or another indicated revision stem to the appropriate surgical technique. Note: It is always necessary to put cerclage wiring around the osteotomised femur in order to ensure implant stability. Figure 16 6 CORAIL Hip System Extraction of a CORAIL Stem Surgical Technique DePuy Synthes

Third strategy : Transfemoral osteotomy Drill multiple holes in the anterior cortex using a 3.5 mm drill and the drilling template. (Figure 17). At the same time protect the muscle attachment. Perform the osteotomy (Figure 18). Free the other 3 osteo-integrated surfaces of the implant using osteotomes and chisels. Depending on the chosen surgical approach, the femoral window can be posterior, lateral or anterior. The stem is removed, the resected femoral window is closed and stabilised using circumferential cables. Implant a CORAIL stem that extends beyond the distal level of the transfemoral resection and then follow the corresponding surgical technique. If the CORAIL stem is not long enough, reconstruct using a Reef stem (distal interlocking stem), Solution stem or RECLAIM stem. The appropriate surgical technique should be followed. Figure 17 Figure 18 CORAIL Hip System Extraction of a CORAIL Stem Surgical Technique DePuy Synthes 7

Ordering information : For CORAIL stem extraction Flexible Osteotome Kit Cat No. Description 2709-04-001 1 Handle with Quick-Couple End 2709-04-002 Small Slap Hammer 2709-04-004 2 Thin Osteotome 8 mm x 76 mm 2709-04-005 Thin Osteotome 10 mm x 76 mm 2709-04-006 Thin Osteotome 12 mm x 76 mm 2709-04-007 Thin Osteotome 20 mm x 76 mm 2709-04-008 3 Thin Osteotome Curved 12 mm 2709-04-009 Thin Osteotome Curved 20 mm 2709-04-010 Thin Osteotome 8 mm x 127 mm 2709-04-011 Thin Osteotome 10 mm x 127 mm 2709-04-012 Radial Osteotome 10 mm x 127 mm 2709-04-013 Radial Osteotome 12 mm x 127 mm 2709-04-014 Radial Osteotome 14 mm x 127 mm 2709-04-015 Radial Osteotome 16 mm x 127 mm 2709-04-016 Radial Osteotome 20 mm x 127 mm 2709-04-017 Extra Long Osteotome 8 mm x 229 mm 2709-04-018 4 Flex Chisel Blade 8 mm x 64 mm 2709-04-019 Flex Chisel Blade 10 mm x 64 mm 2709-04-020 Flex Chisel Blade 12 mm x 64 mm 2709-04-021 Flex Chisel Blade 20 mm x 64 mm 2709-04-022 Flex Chisel Blade 8 mm x 127 mm 2709-04-023 Flex Chisel Blade 10 mm x 127 mm 2709-04-024 Flex Chisel Blade 12 mm x 127 mm 2709-04-025 Flex Chisel Blade 20 mm x 127 mm 2709-04-100 Flex Osteotome Delivery System D21040 5 Kirchner Drills ø 1.8 mm MDE001 6 Extractor Handle MAI001 7 Slap Hammer A6779 8 CORAIL threaded adapter L93575 9 Drills 3.5 mm L93586 10 Drilling template 1 5 6 7 8 9 2 3 4 10 8 CORAIL Hip System Extraction of a CORAIL Stem Surgical Technique DePuy Synthes

References 1. The Norwegian Arthroplasty Register 1987-2004, Prospective Studies of Hip and Knee Prostheses. http:/www.haukeland.no/nrl/, AAOS, 2005. 2. Vidalain JP. CORAIL Stem Long-Term Results Based upon the 15-Years ARTRO Group Experience. Fifteen Years of Clinical Experience with Hydroxyapatite Coatings in Joint Arthroplastie, Ed. Springer, 217-224, 2004. 3. Røkkum M, Brandt M, Bye K, Hetland KR, Waage S, Reigstad A. Polyethylene Wear, Osteolysis and Acetabular Loosening with an HA Coated Hip Prosthesis. J. Bone and Joint Surg. 81-B, No 4, 1999. 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 Allée Irène Joliot Curie 69800 Saint Priest France Tel: +33 (0)4 72 79 27 27 Fax: +33 (0)4 72 79 28 28 DePuy Orthopaedics, Inc. DePuy International Ltd 0459 700 Orthopaedic Drive St Anthony s Road Warsaw, IN 46581-0988 Leeds LS11 8DT 0086 USA Tel: +1 (800) 366 8143 Fax: +1 (574) 267 7196 England Tel: +44 (0)113 387 7800 Fax: +44 (0)113 387 7890 depuysynthes.com DePuy International Ltd. and DePuy Orthopaedics, Inc. 2013. All rights reserved. CA#DPEM/DPI/0213/0007(1) 9066-00-100 Issued: 12/13