BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 25164249 · Received May 13, 2026

    Report

    Report Number
    1038671-2026-00599
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 13, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG A663458. 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM B410573. 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE B271615. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 B671876. 320-15-05 - EQ REV LOCKING SCREW B669236. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT B638367. 320-38-13 - EQUINOXE REVERSE 38MM HUMERAL CONST LINER +2.5 A131547. 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 TSA, PRESENTED TO THE SURGEON WITH INFECTION REQUIRING A REVISION PROCEDURE. ALL IMPLANTS WERE EXTRACTED AND A CEMENT SPACER WAS PUT IN PLACE. 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 ABLE TO BE OBTAINED. THE EXPLANTED DEVICE IS NOT AVAILABLE AS THEY WERE DISCARDED BY THE CUSTOMER. NO DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85484 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1