Device Dossier

E2 Femoral Stem Cemented 12/14 - Uncoated hip femur prosthesis, modular

Device Dossier for E2 Femoral Stem Cemented 12/14 - Uncoated hip femur prosthesis, modular (Uncoated hip femur prosthesis, modular, Class III, sponsor…

Intended purpose

The E2 stems are intended for replacement of the hip joint in order to reduce pain and restore hip function in comparison with preoperative status. The E2 stems are intended to be used in primary total hip arthroplasty and hemiarthroplasty. They are indicated for hip arthroplasty in order to reduce pain and significant disability in cases of: - Primitive and secondary hip osteoarthritis; - Aseptic osteonecrosis; - Rheumatoid arthritis / inflammatory diseases; - Femur, femoral neck, hip and/or acetabulum fractures; - Hip joint arthroplasty when conservative treatments or other devices have failed.

Functional description

The E2 Femoral Stem is a highly polished double taper, modular, cemented femoral component. The stem is manufactured from a high nitrogen stainless steel alloy with tapered geometry to enhance load transfer and minimise shear stress at the stem to bone cement interface.

TGA Public Summary