BEUDAMED
    FDA Adverse Event Injury Summary report: N

    145-DEG PE 40MM HUM LINER +2.5

    MDR report key: 20668775 · Received November 12, 2024

    Report

    Report Number
    1038671-2024-04368
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    October 22, 2024
    Report Date
    January 14, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862535047
    PMA / PMN Number
    K182536
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANTS: 7000028 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 7061511 320-31-40 - GLENOSPHERE, 40MM 6885686 300-30-08 - EQUINOXE PRESERVE STEM 8MM 7110513 315-35-00 - GLND KWIRE 7117585 320-15-05 - EQ REV LOCKING SCREW 7062567 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT S281361 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S110565 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM S294817 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM S297040 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM 6977883 320-35-08 - SMALL SUPERIOR/POSTERIOR AUGGLENOID PLATE,RIGHT 7110513 315-35-00 - GLND KWIRE 7110513 315-35-00 - GLND KWIRE.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 YEARS AND 11 MONTHS POST INITIAL RIGHT TOTAL KNEE ARTHROPLASTY (TKA), THE PATIENT WAS TRYING TO START HIS CHAINSAW AND THE POLYETHYLENE DISASSOCIATED FROM THE HUMERAL TRAY. IT WAS NOTED THAT THE PATIENT WAS REGULARLY DOING MANUAL INTENSIVE LABOR. THE PATIENT UNDERWENT REVISION AT WHICH TIME THE SURGEON REMOVED THE GLENOSPHERE LINER AND HUMERAL TRAY AND THEY WERE REPLACED WITH A 40MM +4 GLENOSPHERE AND A 0+ HUMERAL TRAY, AND 2.5+MM, 40MM POLYETHYLENE. THE EVENT WAS NOT RELATED TO THE BREAKAGE OF A DEVICE AND DID NOT LEAD TO A 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
    1058861 145-DEG PE 40MM HUM LINER +2.5 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862535047

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention