BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX GSF FEMORAL COMPONENT

    MDR report key: 4142785 · Received September 23, 2014

    Report

    Report Number
    3007963827-2014-00049
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    April 1, 2013
    Report Date
    August 25, 2014
    Manufacturer
    ZIMMER ORTHOPEDIC MFG LTD
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. 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
    591095 NEXGEN CR-FLEX GSF FEMORAL COMPONENT JWH ZIMMER ORTHOPEDIC MFG LTD 61876277

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention