BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX GSF FEMORAL COMPONENT

    MDR report key: 3925659 · Received June 17, 2014

    Report

    Report Number
    1822565-2014-00757
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 PT WAS REVISED DUE TO POSSIBLE LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355838 NEXGEN CR-FLEX GSF FEMORAL COMPONENT MBH ZIMMER, INC. 62205159

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention