BEUDAMED
    FDA Adverse Event Other Summary report: N

    KNEE INSERT

    MDR report key: 1061733 · Received June 16, 2008

    Report

    Report Number
    1644408-2008-00190
    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
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CATALOG NUMBER OR LOT NUMBER PROVIDED. ENCORE WILL CONTINUE TO RESEARCH THIS COMPLAINT, AND WILL SUBMIT A FOLLOW-UP REPORT WHEN THE INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    REVISION SURGERY-POLY WORN OUT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention