inforMED
InjuryKWS

EQUINOXE

Received Jul 1, 2026

Report 1038671-2026-00830 · MDR key 25682270

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 · Male

  • Unspecified Infection

Narrative

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT, WHO HAD RIGHT TSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT¿S SHOULDER WAS INFECTED. ALL IMPLANTS WERE REMOVED AND AN ABX SPACER WAS IMPLANTED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO HOSPITAL REGULATIONS. NO DEVICE IMAGES WERE AVAILABLE. NO FURTHER INFORMATION.