BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEXGEN FLUTED STEM TIBIAL COMPONENT

    MDR report key: 3141004 · Received May 24, 2013

    Report

    Report Number
    1822565-2013-00862
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    August 8, 2011
    Report Date
    April 26, 2013
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 TIBIAL LOOSENING. THERE WAS NOTED TO BE NO ADHESION OF THE BONE CEMENT TO THE UNDERSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231354 UNKNOWN NEXGEN FLUTED STEM TIBIAL COMPONENT KNEE PROSTHESIS JWH ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention