BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 9842210 · Received March 17, 2020

    Report

    Report Number
    1038671-2020-00247
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    November 20, 2019
    Report Date
    March 24, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086518
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF NOT RESECTING ENOUGH BONE TO PROPERLY ASSEMBLE THE HUMERAL TRAY TO THE HUMERAL STEM. THIS IMPROPER ASSEMBLY OF THE HUMERAL TRAY TO THE HUMERAL STEM LIKELY DID NOT ALLOW THE TORQUE DEFINING SCREW TO BE FULLY SEATED, RESULTING IN THE TORQUE DEFINING SCREW BACKING OUT AND SUBSEQUENTLY THE HUMERAL TRAY DISASSOCIATING FROM THE HUMERAL STEM. HOWEVER, THIS CANNOT BE CONFIRMED AS THE EXPLANTED DEVICES FROM THE FIRST REVISION WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 320-42-00, 6090474 - EQUINOXE REVERSE 42MM HUMERAL LINER +0; 320-10-10, 5471713 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10.

    Description of Event or Problem · 1

    AS REPORTED, THIS WAS A SCHEDULED REVISION OF A (B)(6) Y/O MALE PATIENT'S EQUINOX REVERSE SHOULDER. THE REVISION WAS TO REPLACE THE PROXIMAL HUMERAL TRAY DUE TO A LOOSE OR BROKEN REVERSE TORQUE DEFINING SCREW. WE FOUND THAT THE SCREW WAS INTACT AND SEEMED TO BACK OUT AFTER THE TORQUE DEFINING SCREW WAS BROKEN OFF PER THE TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307038 EQUINOXE REVERSE TORQUE DEFINING SCREW KIT KWT EXACTECH, INC. 320-20-00 UNK 10885862086518

    Patients

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