BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 13423460 · Received February 2, 2022

    Report

    Report Number
    1038671-2022-00133
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    December 15, 2021
    Report Date
    June 23, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086563
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE 6261376. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6327221. 320-15-03 - RS GLENOID PLATE L POST AUG, 8 DEG, LEFT 6372301. 320-15-05 - EQ REV LOCKING SCREW 6250582. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 6255022. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM 6265939. 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0 6340484.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF THE GLENOID BASEPLATE NOT ACHIEVING LONG-TERM FIXATION, CAUSING THE COMPRESSION SCREWS TO BEAR THE JOINT LOAD AND EVENTUALLY FRACTURE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND ADEQUATE INFORMATION WAS NOT PROVIDED TO DETERMINE THE ROOT CAUSE OF THE INSUFFICIENT GLENOID BASEPLATE FIXATION.

    Description of Event or Problem · 0

    AS REPORTED, THIS (B)(6) MALE PATIENT'S LEFT SHOULDER WAS REVISED DUE TO THE BASEPLATE SCREWS BREAKING. THE BASEPLATE, GLENOSPHERE, TRAY, AND LINER WERE REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233651 EQUINOXE EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM KWT EXACTECH, INC. 320-20-34 UNK 10885862086563

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization| R