BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK NEXGEN LCCK FEMORAL COMPONENT

    MDR report key: 3934624 · Received June 26, 2014

    Report

    Report Number
    1822565-2014-00786
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    April 30, 2012
    Report Date
    May 30, 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 PT WAS REVISED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372957 UNK NEXGEN LCCK FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention UNK NEXGEN TIBIAL COMPONENT, CAT#UNK, LOT#UNK