Device Dossier
PROFEMUR® XM Classic Femoral Stem - Uncoated femoral stem prosthesis, one-piece
Device Dossier for PROFEMUR® XM Classic Femoral Stem - Uncoated femoral stem prosthesis, one-piece (Uncoated femoral stem prosthesis, one-piece, Class…
- GMDN category: Uncoated femoral stem prosthesis, one-piece
Intended purpose
A total hip system component intended to replace the femur. Indications include use in cemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Functional description
PROFEMUR® XM Classic Femoral Stems are dual-taper, cemented stems, offered in three lengths and two types of offsets. The standard length is offered in sizes 00-4 for the straight neck offset and sizes 0-4 for the Varus 8° neck offset. The long length and extra-long length are offered in size 1 for the straight neck offset and the Varus 8° neck offset. The stems are mirror polished and intended to reduce the friction between the cement and implant.