BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 369571 · Received January 3, 2002

    Report

    Report Number
    1644408-2001-00023
    Event Type
    Other
    Date Received
    January 3, 2002
    Date of Event
    December 1, 2001
    Report Date
    December 31, 2001
    Manufacturer
    ENCORE ORTHOPEDICS, INC.
    Product Code
    HRY
    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
    1 FOUNDATION KNEE SYSTEM FOUNDATION TIBIAL INSERT HRY ENCORE ORTHOPEDICS, INC. * 366531

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention