BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TM TIBIAL COMPONENT

    MDR report key: 4223374 · Received October 29, 2014

    Report

    Report Number
    1822565-2014-01460
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING, OSTEOLYSIS AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692718 NEXGEN TM TIBIAL COMPONENT MBH ZIMMER, INC. 62495037

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention