BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN FLUTED STEMMED TIBIAL BROACH

    MDR report key: 1923209 · Received November 9, 2010

    Report

    Report Number
    1822565-2010-01093
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: WITHOUT ADDITIONAL INFORMATION, THE EXACT CAUSE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME. EVALUATION: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. THE TIBIAL BROACH WAS RETURNED FOR EVALUATION. AS RETURNED, THERE IS A MISSING BLADE AT THE TOP OF THE ROW OF BLADES ON THE POSTERIOR SIDE OF THE BROACH. M/L AND A/P MEASUREMENTS WERE TAKEN AND FOUND TO BE WITHIN SPECIFICATIONS. THE RC HARDNESS WAS TESTED AND FOUND TO BE WITHIN SPECIFICATIONS ALSO. THIS PRODUCT WAS MANUFACTURED IN FEBRUARY 2008, BUT IT IS UNK HOW MANY TIMES THIS PRODUCT HAS BEEN USED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE BROACH FRACTURED DURING IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN FLUTED STEMMED TIBIAL BROACH KNEE INSTRUMENT JWH ZIMMER INC 60910717

    Patients

    Seq Age Sex Outcome Treatment
    1