Device Dossier

Titanium Modular Head Sleeve 12/14 Taper - Femoral head/stem prosthesis adaptor

Device Dossier for Titanium Modular Head Sleeve 12/14 Taper - Femoral head/stem prosthesis adaptor (Femoral head/stem prosthesis adaptor, Class III,…

Intended purpose

Femoral Heads are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Femoral Heads are indicated for individuals for inflammatory degenerative joint disease including rheumatoid arthritis; congenital dysplasia; femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; and fracture dislocation of the hip.

Functional description

The sleeves have a 12/14 taper and different neck offset adjustments to better match patient needs. The inner and outer taper of the component are intended to provide a mechanically-locked fit against the modular head and femoral stem components. The sleeve is placed on the femoral taper and the modular head is placed on the sleeve and impacted.

TGA Public Summary