BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PEGGED TIBIAL COMPONENT

    MDR report key: 2971068 · Received February 15, 2013

    Report

    Report Number
    1822565-2013-00334
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 16, 2013
    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

    EVAL SUMMARY: NO DEVICES, PHOTOS, X-RAYS OR SURGICAL REPORTS WERE RECEIVED. BASED ON THE AVAILABLE INFO, THE REPORTED POSTERIOR MIGRATION AND LOOSENING OF THE TIBIAL COMPONENT IS LIKELY THE RESULT OF THE TRAUMA CAUSED BY THE MOTOR VEHICLE ACCIDENT. THE LOT NUMBER OF THE TIBIAL COMPONENT IS UNK; THEREFORE, REVIEW OF ITS DEVICE HISTORY RECORDS IS NOT POSSIBLE. 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. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REPORTED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND AS RESULT THE PT'S TIBIAL COMPONENT WAS PUSHED POSTERIOR AND LOOSENED. PT WAS THEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69838 NEXGEN PEGGED TIBIAL COMPONENT JWH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention