Device Dossier

AMIStem P Cementless 12/14 Ti + HA Coated - Press-fit hip femur prosthesis, one-piece

Device Dossier for AMIStem P Cementless 12/14 Ti + HA Coated - Press-fit hip femur prosthesis, one-piece (Press-fit hip femur prosthesis, one-piece,…

Intended purpose

The AMIStem-P Cementless Stem 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

AMIStem-P is a straight triple tapered femoral stem of rectangular cross-section for use in hip arthroplasty, and is manufactured from Ti-6Al-7N. The stem surface has both horizontal and vertical macrostructures to increase the contact surface and improve implant stability. The proximal part of the stem is coated with a porous Ti layer and the whole stem body is coated with HA. The neck is mirror polished in order to minimize the wear due to occasional contact between neck and cup.

TGA Public Summary