BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENCORE FEMORAL HEAD COMPONENTS

    MDR report key: 1112024 · Received August 14, 2008

    Report

    Report Number
    1644408-2008-00258
    Event Type
    Other
    Date Received
    August 14, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT WAS NON-COMPLIANT AND HAD TO BE REVISED DUE TO MULTIPLE DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE FEMORAL HEAD COMPONENTS COCR FEMORAL HEAD, MM 28/NEU KWY ENCORE MEDICAL, L.P. 527211

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 431-28-010