BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID LARGE, BETA

    MDR report key: 23352258 · Received October 21, 2025

    Report

    Report Number
    1038671-2025-03165
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    September 25, 2025
    Report Date
    October 21, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    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

    D10: 6171048 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM 6201858 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S 6275201 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT 6056314 310-01-47 - EQUINOXE, HUMERAL HEAD SHORT, 47MM (BETA) 5209363 531-78-20 - SHOULDR GPS HEX PINS KIT SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED A 72-YEAR-OLD MALE PATIENT WHO HAD A LEFT TSA IMPLANT, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. A LOOSE GLENOID AND BAD ROTATOR CUFF WAS INDICATED. THEY WERE CONVERTED TO A REVERSE. THERE WAS NO DEVICE BREAKAGE OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN DUE TO CHAIN OF COMMAND. A DEVICE IMAGE WAS PROVIDED. THE CENTER PEG APPEARS TO BE FRACTURED. NO FURTHER INFORMATION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226998 EQUINOXE CAGE GLENOID LARGE, BETA PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| H