BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID M, POST AUG, LEFT

    MDR report key: 20352327 · Received October 2, 2024

    Report

    Report Number
    1038671-2024-03788
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    September 16, 2024
    Report Date
    July 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862196170
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: A10012 - GPS IMPLANT KIT V2 11021019075 314-13-23 - EQUINOXE CAGE GLENOID M, POST AUG, LEFT 5951167 300-30-10 - EQUINOXE PRESERVE STEM 10MM 6107305 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S 6373379 300-20-02 - EQUINOXE SQUARE TORQUE DEFINE SCREW DRIVE KIT 6405006 531-78-20 - SHOULDR GPS HEX PINS KIT 6411366

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS AND 6 MONTHS POST THE INITIAL LEFT TSA, THE PATIENT COMPLAINED OF PAIN AND WAS REVISED DUE TO ASEPTIC LOOSENING. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35606 EQUINOXE CAGE GLENOID M, POST AUG, LEFT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862196170

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention SEE H11