BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXTGEN LCCK ART SURFACE WITH LOCKING SCREW

    MDR report key: 1940889 · Received December 23, 2010

    Report

    Report Number
    1822565-2010-01472
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. 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 DISLOCATION OF THE ARTICULAR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXTGEN LCCK ART SURFACE WITH LOCKING SCREW KNEE PROSTHESIS JWH ZIMMER, INC. 61105597

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention