BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN COMPLETE KNEE

    MDR report key: 2030809 · Received March 22, 2011

    Report

    Report Number
    MW5019923
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 9, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFECTIVE IMPLANT REMOVED FROM LEFT KNEE. PICTURES TAKEN OF BROKEN HINGE MECHANISM. HAS REQUIRED A RETURN TRIP TO THE OPERATING ROOM FOR REPLACEMENT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN COMPLETE KNEE SOLUTION ROTATING HINGE 1-ARTICULAR SURFACE JWH ZIMMER 61101286
    2 NEXGEN COMPLETE KNEE KNEE JWH ZIMMER 60751297

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability