BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUNDATION KNEE INSTRUMENT

    MDR report key: 1934457 · Received November 23, 2010

    Report

    Report Number
    1644408-2010-00631
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - WHILE IMPACTING, A PIECE CHIPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE INSTRUMENT TIBIAL INSERT IMPACTOR BLOCK HWA ENCORE MEDICAL, L.P. 53995551

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR