inforMED
InjuryKWS

EQUINOXE PRIMARY SHOULDER COMPONENTS

Received Jul 20, 2026 · Event occurred Jul 2, 2026

Report 1038671-2026-00921 · MDR key 25884000

Device

Generic name

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Manufacturer

Exactech, Inc.

Product problems

  • Unstable

Patient

NA · Male

  • Muscle/Tendon Damage

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WHO HAD A RIGHT TOTAL SHOULDER ARTHROPLASTY, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 9 MONTHS POST. THE PATIENT WAS REVISED DUE TO INSTABILITY AND SUBSCAP TENDON FAILURE. THEY WERE CONVERTED FROM AN ANATOMICAL TO A REVERSE. THERE WERE NO REPORTED DEVICE BREAKAGES OR SURGICAL DELAYS/PROLONGATIONS. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.