BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN LPS-FLEX FEMORAL COMPONENT

    MDR report key: 2913492 · Received December 21, 2012

    Report

    Report Number
    1822565-2012-02613
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WHEN THE SURGEON TRIED TO SET THE FEMORAL COMPONENT WITH BONE CEMENT, HE FOUND THAT THERE WERE SCRATCHES ON THE SIDE OF FEMORAL COMPONENT. HE USED OTHER TYPE NEXGEN FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN LPS-FLEX FEMORAL COMPONENT JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1