Device Dossier

C-Stem AMT Revision Femoral Implant - Uncoated femoral stem prosthesis, modular

Device Dossier for C-Stem AMT Revision Femoral Implant - Uncoated femoral stem prosthesis, modular (Uncoated femoral stem prosthesis, modular, Class III,…

Intended purpose

A component of a total or hemi hip arthroplasty, the C-Stem AMT Revision femoral implant is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation during revision surgery in skeletally mature patients where there is evidence of sufficient sound bone to seat and support the components, and in the case of a hemi-hip prosthesis, satisfactory natural acetabulum and sufficient bone seat and support the femoral stem. The total hip replacement is indicated in the following conditions: 1. A severely painful and/or arthritic joint (typically due to noninflammatory degenerative joint disease). 2. Failed previous hip surgery. 3. Acute fracture of the femoral head or neck; while the hemi hip replacement is indicated in the following conditions: 1. Acute fracture of the femoral head or neck.

Functional description

The C-STEM AMT Revision femoral implant is a cemented hip prosthesis manufactured from high nitrogen stainless steel. A femoral head is placed on the proximal end of the 12/14 tapered stem which then articulates with the acetabulum. The C-Stem AMT Revision femoral implant can be used either as part of a total hip arthroplasty or as part of a hemi hip arthroplasty in cases where there is satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral implant.

TGA Public Summary