BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CRUCIATE RETAINING FEMORAL COMPONENT

    MDR report key: 1950112 · Received December 7, 2010

    Report

    Report Number
    1822565-2010-01295
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    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 PT IS PRESENTING WITH PAIN. LOOSENING OF THE FEMORAL COMPONENT IS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CRUCIATE RETAINING FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC. 60569945

    Patients

    Seq Age Sex Outcome Treatment
    1