BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 25155032 · Received May 12, 2026

    Report

    Report Number
    1038671-2026-00587
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 12, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862535030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 308-01-13 - 13X80MM DISTAL STEM MODULAR CEM: 7222165. 308-05-31 - DISTAL FIXATION RING HA 31.5: 7222498. 308-09-00 - SMALL PROX BODY +0 7: 001300. 308-15-01 - TAPER LOCKING SCREW 0: B642041. 320-10-00 - EQ REV TRAY ADAPTER PLATE TRAY +0: B841281. 320-15-05 - EQ REV LOCKING SCREW: B803821. 320-20-00 - EQ REV TORQUE DEFINING SCREW KIT: B821452. 320-31-40 - GLENO, 40MM FOR SMALL REVERSE: B634875. 320-35-08 - SMALL SUP./POST. AUG GLENOID PLATE,RIGHT: B082346. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT, WHO HAD A RIGHT RTSA, UNDERWENT A REVISION PROCEDURE. THE PATIENT WAS REVISED DUE TO INSTABILITY. THE SURGEON EXTRACTED THE STANDARD 40MM HUMERAL LINER AND REPLACED IT WITH A 40MM +2.5MM HUMERAL LINER. THERE WAS NO SURGICAL DELAY OR DEVICE BREAKAGE DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. THEY WERE DISCARDED BY THE CUSTOMER. NO IMAGES WERE ABLE TO BE OBTAINED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226252 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862535030

    Patients

    Seq Age Sex Outcome Treatment
    1