Device Dossier

S-ROM Metal Femoral Head - Metallic femoral head prosthesis

Device Dossier for S-ROM Metal Femoral Head - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor DePuy Synthes). ARTG…

Intended purpose

The S-ROM Metal Femoral Head is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post traumatic arthritis, collagen disorders, avascular necrosis and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.

Functional description

The S-ROM Metal Femoral Head is made from Co-Cr-Mo which affixes to a 11/13 tapered femoral stem and articulates with the natural acetabulum in hemi prosthesis or a corresponding diameter implanted acetabular polyethylene liner in total hip arthroplasty.

TGA Public Summary