BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE

    MDR report key: 2780711 · Received October 5, 2012

    Report

    Report Number
    1822565-2012-02044
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    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 PT WAS REVISED DUE TO THE LOCKING SCREW BACKING OUT ON THE LCCK ARTICULAR SURFACE. THE LCCK ARTICULAR SURFACE WAS IMPLANTED IN 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LCCK ARTICULAR SURFACE JWH ZIMMER INC 61468287

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention