BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR FEMORAL COMPONENT

    MDR report key: 4749038 · Received May 1, 2015

    Report

    Report Number
    3007963827-2015-00013
    Event Type
    Injury
    Date Received
    May 1, 2015
    Date of Event
    February 27, 2015
    Report Date
    April 1, 2015
    Manufacturer
    ZIMMER ORTHOPEDIC MFG LTD
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 WAS REPORTED THAT THE SURGEON IMPLANTED THE DEVICE WITHOUT BONE CEMENT BELIEVING IT TO BE A POROUS DEVICE. PATIENT HAS BEEN MADE AWARE OF THE SITUATION AND HAS DECIDED NOT TO HAVE A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289469 NEXGEN CR FEMORAL COMPONENT JWH ZIMMER ORTHOPEDIC MFG LTD 62834981

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other