BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 1230265 · Received November 7, 2008

    Report

    Report Number
    1644408-2008-00401
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 29, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    FLEXURE CONTRACTURE AND NEEDED NEW SIZE IMPLANT. ORIGINAL SURGERY DATE AND DEVICE INFORMATION ARE UNKNOWN, EXCEPT THAT THE ORIGINAL SURGERY WAS PERFORMED IN ANOTHER STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK TIBIAL INSERT HSH ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention