BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN FLUTED STEMMED TIBIAL COMPONENT

    MDR report key: 2082953 · Received May 3, 2011

    Report

    Report Number
    1822565-2011-01082
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    July 16, 2009
    Report Date
    April 5, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO 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 PT WAS REVISED FOR LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN FLUTED STEMMED TIBIAL COMPONENT JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention