Device Dossier

Quadra-P Cemented Stem 12/14 - Uncoated hip femur prosthesis, one-piece

Device Dossier for Quadra-P Cemented Stem 12/14 - Uncoated hip femur prosthesis, one-piece (Uncoated hip femur prosthesis, one-piece, Class III, sponsor…

Intended purpose

The hip prosthesis is designed for use in total or partial hip arthroplasty to provide increased patient mobility and reduced pain by replacing the damaged hip joint, in primary or revision surgery. Total hip Arthroplasty is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia. • Avascular necrosis of the femoral head. • Acute traumatic fracture of the femoral head or neck. • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty. Partial hip arthroplasty is indicated in the following cases: • Acute traumatic fracture of the femoral head or neck. • Non-union of femoral neck fracture. • Avascular necrosis of the femoral head. • Primary pathology involving the femoral head but with a non deformed acetabulum.

Functional description

The Quadra-P Cemented Stem is a cemented, straight stem manufactured from high nitrogen stainless steel. The stem has a mirror polish on the neck region in order to minimize wear due to occasional contact between the neck and cup. The body of the stem also has a mirror finish to avoid the release of wear debris caused by abrasion between the cement mantle and the implant. The stems have a 12/14 taper angle.

TGA Public Summary