BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS PRECOAT STEMMED TIBIAL PLATE

    MDR report key: 4223454 · Received October 29, 2014

    Report

    Report Number
    1822565-2014-01477
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692805 NEXGEN MIS PRECOAT STEMMED TIBIAL PLATE JWH ZIMMER INC 60634793

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention