BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STEMMED NONAUGMENTABLE TIBIA

    MDR report key: 1880268 · Received October 19, 2010

    Report

    Report Number
    2648920-2010-00055
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ZIMMER
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: X-RAYS WERE NOT PROVIDED. WITH OUT ADD'L INFO, THE EXACT CAUSE OF THE TIBIAL PLATE LOOSENING CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVAL: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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 ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN STEMMED NONAUGMENTABLE TIBIA KNEE PROSTHESIS JWH ZIMMER 60106910

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention