BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 1040649 · Received May 7, 2008

    Report

    Report Number
    1644408-2008-00166
    Event Type
    Other
    Date Received
    May 7, 2008
    Date of Event
    November 14, 2005
    Report Date
    May 7, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS FIRST REVISION SURGERY. SECOND REVISION SURGERY, TIBIAL BASEPLATE, PAIN, 2007. ENCORE NOT NOTIFIED OF FIRST REVISION. FIRST REVISION WAS IDENTIFIED DURING THE INVESTIGATION OF THE 2ND REVISION.

    Description of Event or Problem · 1

    REVISION SURGERY - TIBIAL INSERT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM TIBIAL INSERT HSH ENCORE MEDICAL, L.P. 300902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention