BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 1061732 · Received June 16, 2008

    Report

    Report Number
    1644408-2008-00197
    Event Type
    Other
    Date Received
    June 16, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HRY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY-FRACTURED MEDIAL CONDYLE. WORN POLY INSERT. IMPLANT IN PLACE FOR 7 YEARS, PATIENT COMPLAINED OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM FEMUR HRY ENCORE MEDICAL, L.P. 616251

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 324-01-110/661001| 355-09-210/723041