Device Dossier

MS-30® Stem Cemented - Uncoated hip femur prosthesis, modular

Device Dossier for MS-30® Stem Cemented - Uncoated hip femur prosthesis, modular (Uncoated hip femur prosthesis, modular, Class III, sponsor Zimmer…

Intended purpose

-Noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis. -Failed previous surgery where pain, deformity, or dysfunction persists. -Revision of previously failed hip arthroplasty.

Functional description

Highly polished stainless steel (Protasul®-S30)femoral stem component used in conjunction with a femoral head component for replacement of the proximal femur in total hip arthroplasty. A 12/14 taper is incorporated in the design of the stem to interlock it with the femoral head. It is intended for cemented use only.

TGA Public Summary