BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE ULTAMET

    MDR report key: 2201945 · Received August 4, 2011

    Report

    Report Number
    MW5021654
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 13, 2011
    Report Date
    August 4, 2011
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE HAD 7 HIP REVISIONS DUE TO METALLOSIS, INFECTION, LOOSENING AND INTRACTABLE PAIN ON BOTH HIPS. I HAVE SUFFERED SEVERE COMPLICATIONS OF OSTEOMYELITIS TO VANCOMYCIN RESISTANT ENTEROCOCCUS THAT HAS A 35 PERCENT MORTALITY, AND ON THIS LAST REVISION I SUFFERED FROM WOUND INFECTION IN THE SAME HIP. I AM NOT COMPLETELY OUT OF THE WOODS YET. I HAD THE ULTAMET SYSTEM IN AND CONVERTED IT TO PLASTIC. I AM STILL HAVING PAIN AND WEAKNESS DUE TO THE SEVERE SYNOVECTOMY DONE ON ME DUE TO METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE ULTAMET ULTAMET KWA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O| R| S