BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE SECTOR II

    MDR report key: 2150773 · Received June 30, 2011

    Report

    Report Number
    MW5021232
    Event Type
    Injury
    Date Received
    June 30, 2011
    Report Date
    June 21, 2011
    Manufacturer
    DEPUY ORTHO
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS IMPLANTED WITH A JOHNSON AND JOHNSON DEPUY PINNACLE METAL ON METAL TOTAL HIP IMPLANT REPLACEMENT ON (B)(6) 2009. THIS STARTED TO FAIL IN (B)(6) 2010 - HIP PAIN - UNUSUAL MARBLING AND DISCOLORATION AT SIGHT. I WALKED WITH A PAINFUL SORE LIMP - ALSO EXPERIENCED HIGH LEVELS OF ANXIETY AND PANIC ATTACKS - (B)(6) 2011, I WAS HOSPITALIZED FOR HIP PAIN - SEIZURE KIDNEY FAILURE THIGH ANXIETY. IMMEDIATELY FOLLOWING, I WENT TO A NEW ORTHO SURGEON FOR A 2ND OPINION. HE ORDERED AN ULTRASOUND - MRI AND TEST FOR METALLOSIS AT (B)(6). METAL TEST SHOWED I HAD HIGH LEVELS OF COBALT AND CHROMIUM IN BLOOD DUE TO EDGE LOADING OR METAL SHAVINGS FROM PROSTHESIS AFTER 14 MONTHS. DR SUGGESTED AN IMMEDIATE REVISION TO TAKE OUT PRODUCT I WAS CLEARLY BEING POISONED FROM. HE HAD TO LEAVE FEMORAL STEM AND REPLACED IT WITH A DIFFERENT SIZE PINNACLE HEAD AND POLYETHYLENE CUP. SURGERY WAS PAINFUL AND DIFFICULT. I STILL HAVE PAIN AND SWELLING AND HAVE A 1/2 INCH DIFFERENTIAL WITH MY LEGS NOW. DR SAID HE COULD NOT PROMISE ME PAIN WOULD GO AWAY, BUT THE METAL ON METAL WAS OUT. I AM NOT ABLE TO WORK AT A RESTAURANT I HAVE BEEN WITH FOR MORE THAN 18 YRS. I NO LONGER HAVE GOOD MOBILITY OR FLEXIBILITY AND STILL HAVE MAJOR PAIN. I CONTINUE TO USE A CANE AND ONLY HAVE 1 CHAIR IN MY HOUSE. I AM COMFORTABLE AT SHORT INTERVALS THEN MUST STRETCH. IT IS TIME FOR THIS PINNACLE HIP SYSTEM TO BE RECALLED AND UNAVAILABLE TO SURGEONS TO PUT IN INNOCENT PTS WHO ARE PROMISED A HIP THAT IS SUPPOSED TO LAST A LIFETIME. PLEASE FEEL FREE TO CONTACT ME AS I CONTINUE TO SUFFER FROM THIS INTERIOR PRODUCT I HAVE BEEN ROBBED OF MANY LIFE'S SIMPLEST EVERYDAY PLEASURES AS WELL AS A HUGE FINANCIAL BURDEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE SECTOR II ACETABULAR CUP KWA DEPUY ORTHO D52ET1000
    2 DEPUY PINNACLE METAL INSERT METAL INSERT LPH DEPUY ORTHO 3002300
    3 DEPUY ARTICUL/EZE METAL ON METAL FEMORAL HEAD FEMORAL HEAD JDI DEPUY ORTHO 3029905
    4 SUMMIT FEMORAL STEM FEMORAL STEM LWJ DEPUY ORTHO D5PDP1

    Patients

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