BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN PROVISIONAL STEMMED TIBIAL COMPONENT

    MDR report key: 2193018 · Received July 21, 2011

    Report

    Report Number
    1822565-2011-01685
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RETURNED, A PORTION OF THE DEVICE HAS FRACTURED. THERE IS A SLIGHT AMOUNT OF SCRAPING AND GOUGING ON THE TOP SURFACE. THIS FRACTURE WAS POTENTIALLY CAUSED BY REPEATED IMPACTION OR INDUCED BEHIND MOMENTS. WITHOUT FURTHER INFO, HOWEVER, THE EXACT CAUSE OF THE FRACTURE CANNOT BE DETERMINED. EVALUATION: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATIONS. DIMENSIONS TAKEN ARE WITHIN SPECIFICATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE DOING A TRIAL, THE PROVISIONAL BROKE DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN PROVISIONAL STEMMED TIBIAL COMPONENT LXH ZIMMER INC 60886809

    Patients

    Seq Age Sex Outcome Treatment
    1