BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK ART SURFACE W/LOCKING SCREW

    MDR report key: 3213760 · Received July 3, 2013

    Report

    Report Number
    1822565-2013-01073
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 THE SCREW BREAKING INSIDE THE TIBIAL TRAY AND BACKING OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304818 NEXGEN LCCK ART SURFACE W/LOCKING SCREW JWH ZIMMER, INC. 61043810

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention