BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUNDATION KNEE

    MDR report key: 1900524 · Received October 28, 2010

    Report

    Report Number
    1644408-2010-00573
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Product Code
    HTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE TIBIAL BROACH, THE IMPACTOR PLATE DISLODGED FROM THE BROACH STEM HANDLE UPON FINAL IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE BROACH ASSEMBLY, TIBIAL HTQ 37641L01

    Patients

    Seq Age Sex Outcome Treatment
    1