BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK NEXGEN TIBIAL COMPONENT

    MDR report key: 4092117 · Received August 21, 2014

    Report

    Report Number
    1822565-2014-01011
    Event Type
    Injury
    Date Received
    August 21, 2014
    Date of Event
    December 6, 2012
    Report Date
    July 24, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS REVISED DUE TO A LOOSE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504572 UNK NEXGEN TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR