Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Class III
DePuy Ireland UC Loughbeg Ringaskiddy, Co Cork Ireland
38156 - Ceramic femoral head prosthesis
A biolox delta TS Ceramic Femoral Head is composed of a packaged BIOLOX Delta Ceramic Femoral Head with metal tapered sleeve adapters. The BIOLOX delta TS Ceramic Femoral head is manufactured from BIOLOX delta alumina matrix composite ceramic. The BIOLOX delta TS Ceramic Head is intended to allow assembly with DePuy femoral hip stem tapers, either in a primary hip replacement surgery, or in revision hip replacement surgery with well-fixed femoral stems. The DePuy Delta Taper Sleeve (TS) Ceramic Femoral Head is intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis.
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2019-02-01