BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT

    MDR report key: 1895484 · Received November 4, 2010

    Report

    Report Number
    1822565-2010-01076
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 LOOSENING OF THE TIBIAL BASEPLATE AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN FLUTED STEM MOBILE TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. 69308500

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention