Device Dossier

Arthrex® Univers Revers™ Humeral Insert - Reverse shoulder prosthesis cup

Device Dossier for Arthrex® Univers Revers™ Humeral Insert - Reverse shoulder prosthesis cup (Reverse shoulder prosthesis cup, Class III, sponsor…

Intended purpose

Arthrex® Univers Revers™ Humeral Insert is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. It is indicated for primary or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Functional description

The UHMWPE liner optimizes soft‐tissue balance. It is accommodated within the humeral metaphysics component and is congruent with the glenoid sphere. The constrained liner has greater wall height, making dissociation from the glenosphere less likely.

TGA Public Summary