Device Dossier

Redapt Fully Porous Acetabular Shells - Acetabular shell

Device Dossier for Redapt Fully Porous Acetabular Shells - Acetabular shell (Acetabular shell, Class III, sponsor Smith & Nephew). ARTG record, intended…

Intended purpose

The REDAPT Porous Acetabular Shells are designed for uncemented fixation. Bone cement may be used to join augments within the REDAPT Porous Acetabular Shells. The REDAPT Porous Acetabular Shell for use with the POLARCUP Dual Mobility System is to be implanted without bone cement. The POLARCUP Dual Mobility System is to be implanted in the REDAPT Porous Acetabular Shell 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 degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip In Australia, the REDAPT Acetabular System is indicated for revision surgery only.

Functional description

The REDAPT Porous Acetabular Shell incorporates both solid sections and sections that are porous through the shell thickness. The solid sections are at the rim, acetabular screw holes, and the threaded hole at the pole which interfaces with the shell inserter. The fully porous structure allows for early bony in-growth and creates the initial stability required during revision surgery. The REDAPT Porous Acetabular Shell is designed to allow cementing of the liner.

TGA Public Summary