Device Dossier
Zimmer® M/L Taper Hip Femoral Stem HA/TCP - Coated hip femur prosthesis, modular
Device Dossier for Zimmer® M/L Taper Hip Femoral Stem HA/TCP - Coated hip femur prosthesis, modular (Coated hip femur prosthesis, modular, Class III,…
- GMDN category: Coated hip femur prosthesis, modular
Intended purpose
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures neck.
Functional description
Femoral component of a modular hip prosthesis system for total hip arthroplasty with a Morse-type 12/14 taper designed to mate with the corresponding bore of a metal or specified ceramic femoral head component. It is made from Tivanium® Ti-6Al-4V Alloy. The femoral stem has a porous coating of titanium plasma spray and is also coated with Calcicoat® Ceramic Coating (HA/TCP). The Stem is designed for use without bone cement.