BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1220523 · Received October 29, 2008

    Report

    Report Number
    1644408-2008-00390
    Event Type
    Other
    Date Received
    October 29, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VERY LITTLE INFORMATION PROVIDED. ENCORE WILL CONTINUE TO RESEARCH THIS COMPLAINT AND WILL SUBMIT A FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    REVISION SURGERY - BROKEN STEM ON TIBIAL POLY DUE TO PATIENT WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE NONE HSH ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention