Cobalt Chrome Femoral Head 12/14 Taper - Metallic femoral head prosthesis

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Available from:

Smith & Nephew Pty Ltd

Class:

Class III

Manufactured by:

Smith & Nephew Inc Orthopaedic Division 1450 E Brooks Road, Memphis, TN, 38116 United States Of America

Therapeutic area:

33175 - Metallic femoral head prosthesis

Therapeutic indications:

A sterile implantable artificial femoral head that is made of a Cobalt Chrome alloy. It is designed to mate with a hip stem through a corresponding 12/14 taper and to articulate with a polyethylene acetabular prosthesis as part of a total hip arthroplasty. Following a trial reduction with a femoral head trial, the neck taper of the stem is wiped clean with a sterile cloth and the femoral head is placed onto the neck taper and firmly impacted with a mallet. A sterile femoral head component of a total hip system. It attaches to the trunnion of a femoral stem prosthesis and articulates with an acetabulum prosthesis. Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Authorization status:

A

Authorization date:

2013-12-05

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