BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN CR-FLEX GSF FEMORAL COMPONENT

    MDR report key: 3830186 · Received March 26, 2014

    Report

    Report Number
    3007963827-2014-00013
    Event Type
    Injury
    Date Received
    March 26, 2014
    Date of Event
    September 23, 2013
    Report Date
    February 24, 2014
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES OR PHOTOS WERE RECEIVED, THEREFORE, THE CONDITION OF THE COMPONENTS IS UNK. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED. IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. THE DEVICE HISTORY RECORDS FOR THE FEMORAL COMPONENT WERE REVIEWED, INDICATING THE DEVICE WAS MANUFACTURED, INSPECTED, AND PACKAGED TO SPECIFICATION. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176661 NEXGEN CR-FLEX GSF FEMORAL COMPONENT JWH ZIMMER 61809716

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention