Device Dossier

AMIStem-H Collared Cementless Stem 12/14 - Press-fit hip femur prosthesis, one-piece

Device Dossier for AMIStem-H Collared Cementless Stem 12/14 - Press-fit hip femur prosthesis, one-piece (Press-fit hip femur prosthesis, one-piece, Class…

Intended purpose

AMIStem H Collared Cementless Stem to be used in total or partial hip arthroplasty, for primary or revision surgery. The hip prosthesis is designed 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 AMIStem-H HA coated stem has a triple tapered design that provides stability with optimal anchoring to the bone, and the rectangular section allows stability and preservation of bone vascularisation. The horizontal and vertical macrostructures increase the stability and augments the contact surface area by 10-15%. The double tapered distal tip reduces the risk of stress peak in the diaphysis. The collar is designed to prevent subsidence in patients that present Dorr Type C bone.

TGA Public Summary