BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 362264 · Received November 26, 2001

    Report

    Report Number
    1644408-2001-00021
    Event Type
    Other
    Date Received
    November 26, 2001
    Date of Event
    October 1, 2001
    Report Date
    November 21, 2001
    Manufacturer
    ENCORE ORTHOPEDICS, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TIBIAL INSERT REVISED DUE TO BROKEN POST CAUSED BY IMPLANT MISALIGNMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53035 FOUNDATION KNEE SYSTEM TIBIAL INSERT HSH ENCORE ORTHOPEDICS, INC. -- 147531

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention