BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

    MDR report key: 20735319 · Received November 20, 2024

    Report

    Report Number
    1038671-2024-04445
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    July 25, 2023
    Report Date
    December 12, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086419
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF INCOMPLETE SEATING OF THE LINER DURING IMPLANTATION, BONE IMPINGEMENT, PATIENT-RELATED CONDITIONS, AN UNREPORTED POST-TRAUMATIC EVENT, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO HUMERAL LINER DISASSOCIATION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): GLENOSPHERE 42MM 320-01-42 6154427 HUMERAL LINER 42MM, +2.5MM 320-42-03 4483543 GLENOSPHERE LOCKING SCREW 320-15-05 6113795 REVERSE SHOULDER TORQUE DEFINING SCREW 320-20-00 6115379 RS GLENOID PLATE SUP AUG, 10 DEG 320-15-02 5958989 EQUINOXE PRESERVE STEM 11MM 300-30-11 5729693 EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM 320-20-38 5930239 EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM 320-20-38 6113880 EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM 320-20-26 6015034 EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM 320-20-42 6058870.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL RIGHT TSA, THIS 71 Y/O MALE PATIENT WAS REVISED DUE TO HUMERAL LINER DISSOCIATION. HUMERAL LINER WAS DISSOCIATED FROM THE HUMERAL TRAY. GLENOSPHERE, LINER AND TRAY WERE REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. PHOTO ATTACHED. UNABLE TO OBTAIN X-RAYS. PRODUCT NOT RETURNING - DISPOSED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2053862 EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086419

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| H SEE H11.