SURGICAL TECHNIQUE. Protrusio Cage A COMPREHENSIVE ACETABULAR REVISION SYSTEM

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SURGICAL TECHNIQUE Protrusio Cage A COMPREHENSIVE ACETABULAR REVISION SYSTEM

Important: This essential product information does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information. Indications: The Protrusio Cage is intended to be used to reinforce a deficient or weakened medial acetabular wall to prevent the protrusion of an acetabular cup prosthesis into the abdominal cavity. It may be indicated for use in cases involving: acetabular revision procedures; several osteoporosis; Protrusio acetabuli; and/or a shallow acetabular roof. Contraindications: The Protrusio Cage is contraindicated in cases involving: 1. The presence of active/acute infection. 2. Charcot s disease. Warnings and Precautions: The cage has been designed so that it can be rotated to permit bony coverage of its anterior edge. Major defects in the medial wall of the acetabulum may require additional bone grafting. Extrusion of cement into the pelvic cavity through such a defect in the medial wall may hamper subsequent acetabular revision efforts. The following conditions, tending to adversely affect the stable fixation of these implants include: 1. Systematic and metabolic disorders leading to progressive deterioration of solid bone support for implants and bone cement. 2. History of general infectious disease or local infectious disease. 3. Severe deformities leading to impaired anchorage or improper positioning of implants. 4. Tumors of the supporting bone structure. 5. Allergic reactions to the implant material. 6. Congenital dislocation of the hip, which may preclude sufficient bone stock being available to support the acetabular cup. Adverse Events: The following are generally the most frequent adverse events or complications encountered with the Protrusio Cage: 1. Early or late loosening of the prosthetic component, possibly due to factors such as: Improper cement mantle and positioning; inadequate cleaning prior to cementing; improper use of bone grafting; or inadvertent motion while the cement is polymerizing. 2. Acetabular perforation. 3. Temporary or permanent damage to nearby blood vessels, nerves or the bladder. 4. Early or late infection. 5. Subluxation, dislocation or breakage of the device due to improper selection, positioning of components and/or severe osteoporosis. 6. Cardiovascular disorders including venous thrombosis, pulmonary embolism, and heart attack. 7. Hematoma (risk of infection), and/or delayed wound healing. REFERENCES 1. Peters, C., et al. Acetabular Revision with the Bruch-Schneider Antiprotrusio Cage and Cancellous Allograft Bone. Journal of Arthroplasty Mar. 1995: 307-312. 2. Berry, D.J. and M.E. Muller. Revision Arthroplasty Using an Antiprotrusio Cage for Massive Acetabular Bone Deficiencies. Journal of Bone and Joint Surgery (British) Sept. 1992: 711-715.

PROTRUSIO CAGE Introduction DePuy s Protrusio Cage offers a clinically tested treatment option for the revision acetabulum. The Protrusio Cage may be considered as a method of enhancing cemented acetabular reconstruction when traditional biologic fixation with a hemispherical porous-coated acetabular component is not indicated. The Protrusio Cage aids the surgeon in restoring the hip s center of rotation while gaining secure fixation to host or allograft bone through iliac and ischial fixation. By addressing medial wall deficiencies, Protrusio Cages have proven to work well in the revision setting. 1, 2 Features and Benefits Commercially pure titanium allows the implant to be modified to fit patient anatomy Sizing options are available in right and left implants, including 48, 52, 56, 60, 64, 68 and 72mm diameters For cage insertion, a Duraloc Cup impactor can be attached to the Protrusio Cage apical hole Multiple screw holes allow adjunct fixation in the acetabular dome, ilium or ischium Protrusio Cage trials and insertion instrumentation help facilitate contouring and implantation Contoured iliac flange for increased anatomic apposition to bony structures and reduced intraoperative bending Backside grit blasting enhances bony ongrowth Surgical Technique Step1 After removing the failed component, assess the damage to the acetabular bone quality to determine if a Protrusio Cage is the most appropriate treatment alternative. An acetabular trial may be used to gauge approximate cage sizing and to determine the amount of rim loss and allograft requirements. A Protrusio Cage trial or acetabular grater may also be used. Where required, create allograft structures to augment bony support. Ream the acetabulum to determine exact sizing of the cage necessary to bridge the defect.

Step2 Place the Protrusio Cage trial into position and evaluate it for structural support. The cage trial is malleable to enable anatomical contouring. Determine the final size and contour using the cage trial. Step3 Contour the Protrusio Cage implant to mimic the contour of the cage trial. To reduce implant abrasion, it is recommended that a cloth be placed between the implant and the bending pliers. Place the cage implant in position using the insertion and impaction instrumentation. Step4 Upon final impaction, the Protrusio Cage implant ischial wing may be impacted into the ischium, similar to using a blade plate. While maintaining upward dome pressure, use 6.5mm roof pile screws to secure the dome region. Alternatively, where the ischial wing blade plate technique is not used, 6.5mm roof pile screw fixation in the dome, ischium and ilium is recommended. Maintain upward pressure during final impaction. First, secure the dome region using 6.5mm roof pile screws. Then secure the ischium and ilium.

Protrusio Cages Endurance All Poly Cup Implant Trial Inside Outer Implant Inside Outer Cat. No. Cat. No. R/L Diameter (mm) Diameter (mm) Cat. No. Diameter (mm) Diameter (mm) 1011-85-000 2011-15-500 Right 45 48 1011-86-000 2011-16-500 Left 45 48 1011-71-000 2011-01-500 Right 49 52 1223-44-000 28 44 1011-72-000 2011-02-500 Left 49 52 1223-44-000 28 44 1011-73-000 2011-03-500 Right 53 56 1223-46-000 28 46 1011-74-000 2011-04-500 Left 53 56 1223-46-000 28 46 1011-75-000 2011-05-500 Right 57 60 1223-50-000 28 50 1011-76-000 2011-06-500 Left 57 60 1223-50-000 28 50 1011-77-000 2011-07-500 Right 61 64 1223-54-000 28 54 1011-78-000 2011-08-500 Left 61 64 1223-54-000 28 54 1011-81-000 2011-11-500 Right 65 68 1223-58-000 28 58 1011-82-000 2011-12-500 Left 65 68 1223-58-000 28 58 1011-83-000 2011-13-500 Right 69 72 1223-60-000 28 60 1011-84-000 2011-14-500 Left 69 72 1223-60-000 28 60 6.5mm Self Tapping Roof Pile Screws Cat. No. Size (mm) 1011-40-015 15 1011-40-020 20 1011-40-025 25 1011-40-030 30 1011-40-035 35 1011-40-040 40 1011-40-045 45 1011-40-050 50 1011-40-055 55 1011-40-060 60 1011-40-065 65 1011-40-070 70 6.5mm Hex Head Roof Pile Screws Cat. No. Size (mm) 1011-01-501 20 1011-02-501 25 1011-03-501 30 1011-04-501 35 1011-05-501 40 1011-06-501 45 1011-07-501 50 1011-08-501 55 1011-09-501 60 Instruments Cat. No. Description 2011-20-500 Protrusio Cage Case 2011-21-500 Locking Pliers 8 2011-22-500 Impactor Shaft, Protrusio Cage 2011-23-500 Impactor Tip, Protrusio Cage 2011-24-500 Straight Depth Gauge, 70mm

For more information about the Protrusio Cage, visit our web site at www.jnjgateway.com/revisionhip. 1M1105 0611-12-050 (Rev. 2) Printed in USA. 2000 DePuy Orthopaedics, Inc. All rights reserved.