BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 13975678 · Received April 1, 2022

    Report

    Report Number
    1038671-2022-00342
    Event Type
    Injury
    Date Received
    April 1, 2022
    Date of Event
    March 8, 2022
    Report Date
    November 23, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086495
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 320-35-02, 6960981 - SMALL SUPERIOR AUGMENT GLENOID PLATE; 320-31-36, 6917056 - GLENOSPHERE, 36MM. NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S).

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF BOTH THE SCREW BEING CROSS-THREADED IN THE BASEPLATE AND BONE GRAFT OR ALLOGRAFT BEING RETAINED IN THE SCREW-HOLE THREADS, WHICH LED TO INCOMPLETE SEATING OF THE GLENOSPHERE LOCKING SCREW AND GLENOSPHERE AT THE TIME OF IMPLANTATION. THE SYSTEM IS INTENDED TO TRANSMIT FORCES THROUGH THE GLENOSPHERE TO THE GLENOID BASEPLATE. WHEN NOT FULLY SEATED, IT IS POSSIBLE FOR THE FORCES TO BE TRANSMITTED THOUGHT THE GLENOSPHERE AND THE SCREW, CREATING FORCES ON THE SCREW THAT CANNOT BE SUPPORTED.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 5 MONTHS POST OP THE INITIAL RTSA, THIS FEMALE PATIENT WAS REVISED. THE GLENOSPHERE LOCKING SCREW WAS BROKEN CAUSING THE GLENOSPHERE TO DISASSOCIATE FROM THE GLENOID BASEPLATE. SURGEON REPLACED THE GLENOSPHERE, GLENOID, HUMERAL TRAY AND HUMERAL LINER. EVENT STARTED BY DOING NORMAL, EVERYDAY ACTIVITIES. FEMALE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654933 EQUINOXE REV LOCKING SCREW KWT EXACTECH, INC. 320-15-05 UNK 10885862086495

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10