Device Dossier

Trident 0 Degree Constrained Acetabular Insert - Constrained polyethylene acetabular liner

Device Dossier for Trident 0 Degree Constrained Acetabular Insert - Constrained polyethylene acetabular liner (Constrained polyethylene acetabular liner,…

Intended purpose

Designed to replace the articulating surface of the acetabular. Indications: A Constrained Acetabular Insert is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Functional description

Comprised of two preassembled components: an Acetabular Insert and a captured UHR(Universal Head). Acetabular Insert made of polyethylene(UHMWPE) is inserted into a Trident metal acetabular shell. Femoral Head(UHR) made of Cobalt Chrome is connected with a femoral component as part of a Total Hip Arthroplasty. Acetabular insert has a Titanium Alloy retaining ring which retains the UHR in the insert and a CoCr alloy circumferential locking wire for secure assembly of the insert to the metal shell

TGA Public Summary