BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8859626 · Received August 5, 2019

    Report

    Report Number
    1038671-2019-00389
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    July 24, 2019
    Report Date
    October 25, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862242563
    PMA / PMN Number
    K131575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (E3) OCCUPATION: PHYSICIAN (G5) PMA/510(K)NUMBER: K131575 (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF A COMBINATION OF AN INSUFFICIENT BOND BETWEEN THE GLENOID BASEPLATE AND THE BONE AND THE PATIENT¿S BONE QUALITY, WHICH LED TO ASEPTIC (NON-INFECTED) GLENOID LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A3, A5, B6, B7, D6, D7, G8, H4, H6, H7

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: 320-01-42, 42MM GLENOSPHERE; 320-42-00, 42MM HUMERAL LINER; 320-20-38, 38MM SCREW; 320-20-46, 46MM SCREW; 320-20-00, REVERSE TORQUE SCREW; 320-15-05, REVERSE GLENOSPHERE LOCKING SCREW; 320-10-00, 0+ TRAY.

    Description of Event or Problem · 1

    REVISION DUE TO THE PATIENT¿S GLENOID BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653200 EQUINOXE SUP/POST AUG PLATE, R RS GLENOID BASEPLATE KWT EXACTECH, INC. 10885862242563

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R