BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CR-FLEX FEMORAL COMPONENT

    MDR report key: 2891484 · Received December 6, 2012

    Report

    Report Number
    1822565-2012-02497
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Report Date
    November 7, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THE OPERATING ROOM STAFF OPENED THE OUTER BOX, IT WAS DISCOVERED THAT THE INNER STERILE PACKAGES WERE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN CR-FLEX FEMORAL COMPONENT JWH ZIMMER, INC. 60005284

    Patients

    Seq Age Sex Outcome Treatment
    1