BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP SYSTEM

    MDR report key: 1040645 · Received May 7, 2008

    Report

    Report Number
    1644408-2008-00143
    Event Type
    Other
    Date Received
    May 7, 2008
    Date of Event
    April 14, 2008
    Report Date
    May 7, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT'S LEFT HIP BECAME INFECTED THREE WEEKS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP SYSTEM STEM WITH COLLAR KWY ENCORE MEDICAL, L.P. 53800558

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention