BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED TIBIAL COMPONENT

    MDR report key: 3213765 · Received July 3, 2013

    Report

    Report Number
    2648920-2013-00145
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 PAIN AND LOOSENING. IT WAS NOTED THAT THE SYNOVIUM WAS A THICKENED CREAMY GREY COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305781 NEXGEN STEMMED TIBIAL COMPONENT JWH ZIMMER 60707372

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention PALACOS R+G BONE CEMENT,| CATALOG #00111314001, LOT #UNK