BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE

    MDR report key: 3093689 · Received May 1, 2013

    Report

    Report Number
    1822565-2013-00735
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    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 EXPERIENCED HER KNEE CATCHING AND SORENESS. X-RAYS SHOWED THE ARTICULAR SURFACE LOCKING SCREW DISENGAGED AND LOCATED IN THE ANTERIOR ASPECT OF THE KNEE. REVISION WAS PERFORMED. REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189868 NEXGEN LCCK ARTICULAR SURFACE JWH ZIMMER INC 60736424

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention