BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE SHOULDER COMPONENTS

    MDR report key: 17370334 · Received July 21, 2023

    Report

    Report Number
    1038671-2023-01738
    Event Type
    Injury
    Date Received
    July 21, 2023
    Date of Event
    June 27, 2023
    Report Date
    July 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): EQ REV TORQUE SCREW, 320-20-00 5428577 1. EQ REV ADAPTER PLATE TRAY +0, 320-10-00 5498099 1. 36MM CONSTR HUMERAL LINER +2.5, 320-36-13 4968121 1.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS POST OP INITIAL LEFT TSA, THIS 79 Y/O FEMALE PATIENT WAS REVISED DUE TO INSTABILITY ISSUES. HUMERAL ADAPTER TRAY SIZE WAS INCREASED TO +5 WITH A CONSTRAINED LINER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147035 EQUINOXE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-36-13 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female