Device Dossier
TANDEM INTL Bipolar - Femoral head bipolar component
Device Dossier for TANDEM INTL Bipolar - Femoral head bipolar component (Femoral head bipolar component, Class III, sponsor Smith & Nephew). ARTG record,…
- GMDN category: Femoral head bipolar component
- Sponsor: Smith & Nephew
Intended purpose
Smith & Nephew’s TANDEM Bipolar Hip System is indicated for use in patients not suitable for total hip arthroplasty with a non-functional femoral head due to femoral neck fracture.
Functional description
The TANDEM INTL Bipolar is a sterile Co-Cr (cobalt-chrome alloy) shell preassembled with an ultra high molecular weight polyethylene (UHMWPE) liner and a titanium alloy (Ti-6Al-4V) retaining ring to minimize rotational and axial movement at the liner-shell interface. Additionally there is a polyethylene top-locking ring to be placed over the appropriately sized femoral head which is finger-pressed into place flush with the metal shell. The implant articulates against the natural acetabulum.