Device Dossier
REFLECTION INTERFIT POROUS-COATED ACETABULAR SHELL - 0/3 HOLES - Acetabular shell
Device Dossier for REFLECTION INTERFIT POROUS-COATED ACETABULAR SHELL - 0/3 HOLES - Acetabular shell (Acetabular shell, Class III, sponsor Smith &…
- GMDN category: Acetabular shell
- Sponsor: Smith & Nephew
Intended purpose
A titanium alloy porous coated acetabular shell being the outer portion of a two-piece acetabulum prosthesis intended to be used without 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.
Functional description
A porous coated hemispherical acetabular shell featuring a peripheral build-up. The outer rim has a cutout section which permits bone to overhang without affecting polyethylene liner seating. The shell is inserted into the acetabulum and tapped with a mallet until sealed. The apex hole is covered using watertight threaded hole cover and any unused holes, if applicable should be covered using screw hole covers.