BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NK-FLEX SINTERLOCK GSM FEMORAL COMPONENT

    MDR report key: 3042522 · Received April 4, 2013

    Report

    Report Number
    1822565-2013-00600
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 WHEN TRYING TO IMPLANT THE FEMORAL COMPONENT, IT WAS IMPOSSIBLE TO DO IT, SINCE THE FEMORAL CUTS THAT WERE MADE, DID NOT CORRESPOND WITH THE SHAPE OF THE FEMORAL COMPONENT. ANOTHER FEMORAL COMPONENT FROM THE SAME SIZE AND SIDE WAS OPENED, AND IT FITTED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138450 NK-FLEX SINTERLOCK GSM FEMORAL COMPONENT JWH ZIMMER, INC. 11002645

    Patients

    Seq Age Sex Outcome Treatment
    1