BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN TRABECULAR METAL TIBIAL TRAY

    MDR report key: 2091659 · Received April 28, 2011

    Report

    Report Number
    1822565-2011-01052
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D 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 TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN TRABECULAR METAL TIBIAL TRAY MBH ZIMMER INC 61084762

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention