BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 4112885 · Received September 17, 2014

    Report

    Report Number
    1822565-2014-01139
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 23, 2012
    Report Date
    August 19, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 THE PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577102 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT JWH ZIMMER, INC. 61422657

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention LOT #: 61370246| MIS PRECOATED TIBIAL PLATE: CAT #: 00595005701,