BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 1112022 · Received August 14, 2008

    Report

    Report Number
    1644408-2008-00255
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    July 19, 2008
    Report Date
    July 19, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER UNKNOWN. ENCORE WILL CONTINUE TO RESEARCH THE LOT NUMBER ASSOCIATED WITH THIS COMPLAINT AND WILL SUBMIT A FOLLOW-UP REPORT WHEN MORE INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    REVISION SURGERY - POLY SWAP/INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM PS INSERT HSH ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention