BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN CR OPTION FEMORAL COMPONENT

    MDR report key: 3880863 · Received April 9, 2014

    Report

    Report Number
    3007963827-2014-00015
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 10, 2014
    Manufacturer
    ZIMMER,
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 A PIECE OF FIBROUS MATERIAL WAS FOUND IN THE FEMORAL COMPONENT PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213357 NEXGEN CR OPTION FEMORAL COMPONENT JWH ZIMMER, 62545319

    Patients

    Seq Age Sex Outcome Treatment
    1