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.