Device Dossier
Tri-Lock BPS Femoral Stem - Coated hip femur prosthesis, modular
Device Dossier for Tri-Lock BPS Femoral Stem - Coated hip femur prosthesis, modular (Coated hip femur prosthesis, modular, Class III, sponsor DePuy…
- GMDN category: Coated hip femur prosthesis, modular
Intended purpose
The Tri-Lock BPS Femoral Stem is one component of a total or hemi-hip arthroplasty and 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. Additionally, for hemi-hip arthroplasty, where there is evidence of satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem. Indications include: 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.
Functional description
The Tri-Lock BPS Femoral Stem is a modular titanium/aluminium alloy stem with a porous coating (Gription) to allow biological fixation. Tri-Lock BPS Femoral Stem is indicated for cementless use. The 12/14 tape of the Tri-Lock BPS Femoral Stem accepts a corresponding 12/14 taper head.