BEUDAMED
    FDA Adverse Event Injury Summary report: N

    145-DEG PE 42MM HUM LINER +0

    MDR report key: 20429812 · Received October 11, 2024

    Report

    Report Number
    1038671-2024-03951
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    October 1, 2024
    Report Date
    October 11, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086693
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANTS: (B)(6) - GLENOSPHERE 42MM A125798; (B)(6) - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM A000410; (B)(6) - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 A182889; (B)(6) - EQ REV GLENOID PLATE A082616; (B)(6) - EQ REV LOCKING SCREW A145718; (B)(6) - EQ REVERSE TORQUE DEFINING SCREW KIT A176755; (B)(6) - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM A141989; (B)(6) - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM A142022; (B)(6) - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S374681; (B)(6) - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S324056; (B)(6) - 3.2MM DRILL BIT STERILE 6604653; (B)(6) - 3.2MM K-WIRE, TROCAR TIP A131216.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT FELT A POP AND THE POLY DISSOCIATED ON THE RIGHT SIDE AND HAD TO BE REVISED. A NEW POLY AND GLENOSPHERE WERE IMPLANTED DUE TO METAL DEBRIS. ALL FRAGMENTS, PARTS AND PIECES WERE REMOVED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344083 145-DEG PE 42MM HUM LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086693

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H11