BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL KNEE II STEMMED TIBIAL BASEPLATE

    MDR report key: 1844740 · Received September 23, 2010

    Report

    Report Number
    1822565-2010-00809
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 2, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 DURING IMPLANTATION, THE PLUGS OF THE BASEPLATE CAME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL KNEE II STEMMED TIBIAL BASEPLATE KNEE PROSTHESIS JWH ZIMMER, INC. 61494316

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR