BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN NKII DURASUL TIBIAL INSERT

    MDR report key: 3110958 · Received May 9, 2013

    Report

    Report Number
    1822565-2013-00781
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO BREAKAGE, DISLOCATION, LOOSENING, AND WEAR. DURING THE REVISION SURGERY THE ARTICULAR SURFACE WAS FOUND TO BE IN FRONT OF THE TIBIAL TRAY,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202543 NEXGEN NKII DURASUL TIBIAL INSERT JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention