BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT POROUS

    MDR report key: 1993721 · Received January 13, 2011

    Report

    Report Number
    1822565-2011-00081
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    December 9, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. 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 LOOSENING OF THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR-FLEX FEMORAL COMPONENT POROUS KNEE PROSTHESIS HSA ZIMMER, INC. 61318927

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR