BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 3851144 · Received May 23, 2014

    Report

    Report Number
    1822565-2014-00658
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    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 THE PT WAS REVISED DUE TO LOOSENING AND FRACTURE OF MEDIAL CONDYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309248 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT JWH ZIMMER, INC. 61422652

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CAT #00594603009, LOT #61524648,| NEXGEN LPS MOBILE ARTICULAR SURFACE,| RETURNED ON 05/19/2014