BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN MIS TRABECULAR METAL TIBIAL TRAY

    MDR report key: 2092622 · Received May 10, 2011

    Report

    Report Number
    1822565-2011-01139
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PAIN AND LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN MIS TRABECULAR METAL TIBIAL TRAY MBH ZIMMER, INC. 61096608

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention