Ultamet Metal Femoral Head - Metallic femoral head prosthesis

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 公開評価報告書 (PAR)
01-12-2017

から入手可能:

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

クラス:

Class III

製:

Depuy International St Anthony's Road, LEEDS, WEST YORKSHIRE, LS118DT United Kingdom

治療領域:

33175 - Metallic femoral head prosthesis

適応症:

The Ultamet Metal Femoral Head is made from cobalt chrome and press-fits onto a 9/10 tapered femoral stem. It articulates with a polyethylene liner only. The Ultamet Metal Femoral Head is one component of a total or hemi hip arthroplasty. 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. Hemi-hip arthroplasty is indicated where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem for the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly

認証ステータス:

A

承認日:

2015-10-26

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