BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEPUY

    MDR report key: 2113515 · Received May 28, 2011

    Report

    Report Number
    MW5020840
    Event Type
    Death
    Date Received
    May 28, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 28, 2011
    Manufacturer
    JOHNSON AND JOHNSON
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IN THE BEGINNING OF THE (B)(6) OF 2010 MY BROTHER RECEIVED A "PINNACLE" THR. WITHIN THE SAME WEEK HE DEVELOPED A VERY SEVERE INFECTION. HE WOUND UP IN THE ICU AND FINALLY STABILIZED. HE WAS THEN BROUGHT BACK INTO SURGERY HAD THE IMPLANT REMOVED, WOUND LEFT OPEN TO DRAIN AND THEN ANOTHER IMPLANT WAS PERFORMED, A PINNACLE AGAIN. HE WAS RELEASED AND SENT HOME. SEVERAL DAYS LATER HE HAD TO RETURN TO THE HOSPITAL, THE SURGICAL SITE WAS REOPENED, CUP REMOVED, IMPLANT FLUSHED AND CLEANED AND THEN CLOSED. HE WAS RELEASED TO A REHAB CENTER FOR 6 WEEKS. DURING THIS TIME HE COMPLAINED OF EXCRUCIATING PAIN, AND DIFFICULTY WALKING. HE WAS RELEASED HOME AFTER 6 WEEKS IN REHAB. WHEN HE RETURNED HOME HE NEVER COULD RESUME NORMAL ACTIVITIES. YOU COULD HEAR AND FEEL THE IMPLANT CLICKING WHEN HE TRIED TO WALK. IT APPEARED THAT HIS LEFT HIP WAS ABOUT 10" HIGHER THAN HIS RIGHT HIP AS IF IT WAS MISALIGNED AND NOT POSITIONED PROPERLY. ON (B)(6), IT LOCKED UP AND HE WAS ADMITTED BACK INTO THE HOSPITAL ER. X RAYS WERE PERFORMED AND HAIRLINE FRACTURES WERE PRESENT NOW. THIS WAS NOT THE CASE IN HIS EARLIER XRAYS. HE COULD BARELY WALK. I HAD INSTRUCTED HIM TO CHANGE DOCTORS AND GET A FRESH SET OF EYES ON HIS ISSUE. YOU WOULD HAVE TO HAVE KNOWN MY BROTHER, HE WAS THE KINDEST MAN I EVER KNEW AND HE DID NOT WANT TO OFFEND HIS CURRENT DOCTORS. HE STRUGGLED CONTINUOUSLY WITH BASIC DAY TO DAY FUNCTIONS. HE KEPT SOME TYPE OF INFECTION AND IT ACTUALLY WAS OOZING FROM THE CORNER OF HIS EYE. HE ACTUALLY HAD INCISIONS IN HIS LOWER LIDS TO LET IT DRAIN. THIS SHOWED UP IN (B)(6), MONTHS POST IMPLANT. TWO WEEKS AGO HE WAS SHOPPING FOR MY MOTHER AND HIP WENT OUT FROM UNDERNEATH HIM, HE FELL, HIT HIS HEAD. TWO GENTLEMEN SAW HIM FALL AND THEY HELPED HIM BACK TO HIS VEHICLE WHERE MY MOTHER OF (B)(6) OF AGE WAS WAITING FOR HIM. HE BEGAN TO GO IN AND OUT OF CONSCIOUSNESS ONCE IN THE VEHICLE. EMT'S WERE CALLED AND WHEN THEY GOT TO MY BROTHER HE HAD CODED, THEY BROUGHT HIM TO THE ER AND WORKED ON HIM FOR ANOTHER 30 MINUTES WITH NO SUCCESS. HE WAS PRONOUNCED DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE HIP IMPLANT LPH JOHNSON AND JOHNSON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death