BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL KNEE II STEMMED TIBIAL BASEPLATE

    MDR report key: 2191922 · Received July 22, 2011

    Report

    Report Number
    1822565-2011-01703
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FROM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON IMPACTION, THE POLY SCREW PLUG DETACHED FROM AND EXITED OUT THE TOP OF THE BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL KNEE II STEMMED TIBIAL BASEPLATE KNEE PROSTHESIS JWH ZIMMER, INC. 61772935

    Patients

    Seq Age Sex Outcome Treatment
    1