Device Dossier

Trabecular Metal™ Acetabular Revision System Longevity® HXPE Revision Shell Liner, 0 Degree Liner Face Angle, Cemented - Non-constrained polyethylene acetabular liner

Device Dossier for Trabecular Metal™ Acetabular Revision System Longevity® HXPE Revision Shell Liner, 0 Degree Liner Face Angle, Cemented -…

Intended purpose

The TM Longevity Revision Shell 0 Degree Liner is indicated for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Also indicated for cemented use in the TM Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage.

Functional description

The TM Longevity Revision Shell 0 Degree Liner comes in a neutral configuration. The liner is affixed to the TM Revision Shell through a 2-3mm cement mantle. Contains a grooved backside which facilitates cemented fixation between the liner and shell, while also decreasing stresses in cement mantle and providing rotational stability. Manufactured from Longevity Highly Crosslinked Polyethylene. Intended for cemented use.

TGA Public Summary