BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE HIP IMPLANT

    MDR report key: 2132684 · Received June 11, 2011

    Report

    Report Number
    MW5021003
    Event Type
    Injury
    Date Received
    June 11, 2011
    Date of Event
    December 1, 2008
    Report Date
    June 11, 2011
    Manufacturer
    DEPUY
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON (B)(6) 2013: DEPUY PINNACLE HIP DEVICE. I REPORTED THIS BACK A COUPLE OF YEARS AGO. NOBODY CARED AT THAT TIME. NOW PEOPLE ARE TAKING NOTICE SINCE SO MANY ARE NOW CONSIDERED DEFECTIVE. I WISH YOU WOULD GET ON THE BALL AND AT LEAST ISSUE THE RECALL. MY LIFE WAS RUINED BY THIS EVENT AND I HAVE TO TAKE CALLS ALL DAY EVERY DAY FROM BILL COLLECTORS BECAUSE I CAN'T PAY MY BILLS. I WAS DISABLED BY THIS IMPLANT. I LOST MY CAREER, MY HOUSE, EVERYTHING. SINCE YOU DON'T ISSUE THE RECALL, I CAN'T GET ADVANCE AGAINST POSSIBLE FUTURE MONIES FROM LAWSUIT BECAUSE THESE COMPANIES WANT TO SEE THE RECALL. ALL YOU DO IS HURT ALL THE INNOCENT PEOPLE WHO WERE AFFECTED BY THIS FAULTY DEVICE AND LIVES WERE RUINED WHEN IT WAS ALL YOUR FAULT TO BEGIN WITH THAT DEVICE WAS PUT ON THE MARKET WITHOUT EVEN BEING TESTED IN ADVANCE. THERE IS NO DOUBT DEVICE WAS FAULTY. YOU SHOULD TAKEN ACTION SOONER THAN LATER TO KEEP OTHERS FROM GETTING HURT, BE IT IN THE FUTURE. I WAS EVEN DOUBTED SO LONG BY EVEN MY SURGEON BECAUSE ALL OUTSIDE TESTS MADE IT HARD TO SEE DAMAGE WHEN IN FACT WHEN THEY WENT IN STEM WAS JUST SITTING THERE COMPLETELY UNATTACHED. I HAD A HIP IMPLANT BACK IN 2003. IT WAS THE PINNACLE ALSO BUT NOT THE METAL ON METAL, SO I KNEW WHAT TO EXPECT AS FAR AS PAIN LEVEL AND ACTIVITY LEVELS THAT SHOULD BE ACHIEVABLE. THIS ONE JUST WOULDN'T HEAL NO MATTER WHAT. I HAD TO HAVE REVISION 14 MONTHS LATER AND SO MUCH TIME WAS WASTED WHEN THE REVISION COULD HAVE BEEN DONE SOONER TO LET ME START TO HEAL AND GET ON WITH MY LIFE. PLEASE AT LEAST HAVE THE (B)(6) TO GO AHEAD AND MAKE THE RECALL TO MAKE IT EASIER ON THOSE OF US AFFECTED BY THIS JOKE OF A MEDICAL DEVICE. I WOULD LOVE TO BE ABLE TO WORK BUT THE PAIN IS STILL JUST SO MUCH. LIVING ON LIMITED INCOME AT THE AGE OF (B)(6) AND IT IS KILLING ME BECAUSE I AM IN A NO WIN SITUATION. I HOPE YOU AT LEAST GIVE MY OPINION SOME CONSIDERATION. THANK YOU. (B)(6).

    Description of Event or Problem · 1

    HAD HIP REPLACEMENT (B)(6) 2007. DIDN'T HEAL RIGHT. HAD REVISIONS (B)(6) 2008. JOINT WAS LOOSE. REPLACED STEM. TERRIBLE PAIN NOW STILL IN RIGHT LEG AND HIP. STILL TRYING TO GET IN TO SEE DOCTOR TO FIND OUT WHAT IS PROBLEM, BUT I AM PRETTY SURE IT IS GOING TO GO BACK TO MY HIP AGAIN. HAD THE DEPUY PINNACLE IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R| S