BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 3214108 · Received July 3, 2013

    Report

    Report Number
    1644408-2013-00360
    Event Type
    Other
    Date Received
    July 3, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    PMA / PMN Number
    K003250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE PT WAS A CHRONIC DISLOCATOR, TIMES GREATER SEVEN. THE LAST THREE TIMES, THE PT REDUCED HIMSELF, AND WAS LOOSE. IT APPEARS HE WAS "EDGE-LOADING," METAL - METAL LINER DIAMETER SHELL AND SIGNIFICANT METALLOSIS RESULTED. THE SURGEON LAVAGED THE SITE, DEBRIDED THE AFFECTED TISSUE, AND REPLACED THE HEAD AND INSERT (X-ALT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306413 FOUNDATION HIP LINER, METAL-METAL MP9 KWA ENCORE MEDICAL, L.P. 980621

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention 497-28-350, LOT 948651