BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ZIMMER MIS TM TIBIAL TRAY

    MDR report key: 2100579 · Received May 17, 2011

    Report

    Report Number
    1822565-2011-01177
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 20, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    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 DUE TO INFECTION. DURING REMOVAL, THE TRABECULAR METAL WAS COMING OFF OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN ZIMMER MIS TM TIBIAL TRAY MBH ZIMMER, INC. 61703595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention