BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK ARTICULAR SURFACE

    MDR report key: 2120047 · Received June 7, 2011

    Report

    Report Number
    1822565-2011-01334
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS REC'D FROM A FOREIGN SOURCE 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 THE FRACTURE OF THE ARTICULAR SURFACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention