BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 1053293 · Received May 28, 2008

    Report

    Report Number
    1644408-2008-00170
    Event Type
    Other
    Date Received
    May 28, 2008
    Date of Event
    April 28, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    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- BROKEN STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM INSERT, POSTERIOR STABILIZED HSH ENCORE MEDICAL, L.P. 137241

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention