BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1080985 · Received July 23, 2008

    Report

    Report Number
    1644408-2008-00233
    Event Type
    Other
    Date Received
    July 23, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 1, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VERY LITTLE INFO RECEIVED. ENCORE WILL CONTINUE TO RESEARCH THIS COMPLAINT AND WILL SUBMIT A FOLLOW-UP REPORT WHEN ADDITIONAL INFO IS RECEIVED.

    Description of Event or Problem · 1

    REVISION SURGERY - INSERT WAS WORN OUT. DOCTOR AND HOSPITAL DOES NOT HAVE PRIOR SURGERY INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE HSH ENCORE MEDICAL, L.P.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention