REFLECTION POROUS-COATED ACETABULAR SHELL - 0-12 HOLES - Acetabular shell

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 1450 Brooks Rd, Memphis, Tennessee, 38116 United States Of America

Therapeutic area:

43167 - Acetabular shell

Therapeutic indications:

Sterile hemispherical acetabular shell that features porous coating to enhance stability. The shell can present with 0, 3, 8 or 12 holes. The shell is inserted in the acetabulum and tapped with a mallet until seated. The holes, if present are fixed using pegs or screws in pre-drilled holes and any unused holes shall be covered using the screw hole covers. The apex hole shall be covered using a watertight threaded hole cover prior to liner insertion. A sterile acetabular component of a total hip system. REFLECTION POROUS-COATED ACETABULAR SHELL- 0-12 HOLES is a titanium alloy porous coated acetabular shell being the outer portion of a two-piece acetabulum prosthesis intended for revision surgery and to be used with bone cement. 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:

2014-02-18

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