BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLP

    MDR report key: 1230262 · Received November 7, 2008

    Report

    Report Number
    1644408-2008-00387
    Event Type
    Other
    Date Received
    November 7, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    PMA / PMN Number
    K052320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT REQUIRED REVISION SURGERY DUE TO LOOSE COMPONENTS, LIKELY DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLP HIP STEM KWY ENCORE MEDICAL, L.P. 53921375

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 430-01-060| 400-32-400| 432-32-210