Ultamet Metal Femoral Head - Metallic femoral head prosthesis

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Class:

Class III

Manufactured by:

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

Therapeutic area:

33175 - Metallic femoral head prosthesis

Therapeutic indications:

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

Authorization status:

A

Authorization date:

2015-10-26