BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE SYSTEM

    MDR report key: 1053023 · Received May 27, 2008

    Report

    Report Number
    1644408-2008-00163
    Event Type
    Other
    Date Received
    May 27, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 30, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FAILURE INVESTIGATION IS LIMITED IN SCOPE SINCE THE PRODUCT FROM THE REVISION SURGERY WAS NOT SHIPPED TO ENCORE FOR EXAMINATION. IF THE PRODUCT CAN BE LOCATED AT A FUTURE DATE THIS INVESTIGATION WILL BE REOPENED. THE ROOT CAUSE OF THIS REVISION SURGERY IS UNABLE TO BE DETERMINED AS THERE ARE MANY FACTORS THAT CAN CONTRIBUTE TO INFECTION THAT ARE OUTSIDE THE CONTROL OF ENCORE MEDICAL, L.P. INVENTORY CONTAINMENT IS NOT REQUIRED AS IT HAS BEEN DETERMINED THAT THE PTS REVISION SURGERY IS NOT A RESULT OF THE TIBIAL INSERT. ADDITIONALLY, A REVIEW OF THE PRODUCT COMPLAINT DATABASE REVEALS THAT THERE ARE NO SIMILAR COMPLAINTS WITH THIS LOT OF TIBIAL INSERTS. ENCORE CONSIDERS THIS THE FINAL REPORT.

    Description of Event or Problem · 1

    REVISION SURGERY - POLY SWAP AND WASH OUT, DUE TO INFECTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION KNEE SYSTEM INSERT HSH ENCORE MEDICAL, L.P. 301772

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention