BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 1202762 · Received October 13, 2008

    Report

    Report Number
    1644408-2008-00354
    Event Type
    Other
    Date Received
    October 13, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K933539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - UNSTABLE KNEE REQUIRED LARGER INSERT AND PATELLA REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM INSERT, PS, SZ 4 JWH ENCORE MEDICAL, L.P. 471022

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention