inforMED
InjuryKWS

EQUINOXE PRIMARY SHOULDER COMPONENTS

Received Jul 17, 2026 · Event occurred Jul 1, 2026

Report 1038671-2026-00909 · MDR key 25861893

Device

Generic name

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

Manufacturer

Exactech, Inc.

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Arthropathy

Narrative

Description of Event or Problem

AS REPORTED, APPROXIMATELY 10 YEARS POST THE INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO CUFF FAILURE AND SUBSEQUENT HUMERAL HEAD MIGRATION. THE PATIENT WAS REVISED TO A REVERSE PROSTHESIS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.