BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 1112017 · Received August 14, 2008

    Report

    Report Number
    1644408-2008-00250
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 18, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - BROKEN STEM ON 4X9 TIBIAL POLY DUE TO PATIENT WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM PS INSERT JWH ENCORE MEDICAL, L.P. 136691

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention