BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN POROUS STEMMED TIBIAL PLATE

    MDR report key: 2133530 · Received June 15, 2011

    Report

    Report Number
    1822565-2011-01407
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 14, 2009
    Report Date
    May 19, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 PT WAS REVISED DUE TO A LOOSE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN POROUS STEMMED TIBIAL PLATE MBH ZIMMER INC 60575461

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention