BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LCCK FEMORAL COMPONENT

    MDR report key: 3940382 · Received June 18, 2014

    Report

    Report Number
    1822565-2014-00761
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 DISASSOCIATION OF THE STEM AND FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357602 NEXGEN LCCK FEMORAL COMPONENT JWH ZIMMER, INC. 62492687

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention NEXGEN STEM EXTENSION: CAT #00598801018,| LOT #62525514