BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY

    MDR report key: 2021756 · Received March 11, 2011

    Report

    Report Number
    MW5019807
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    November 6, 2006
    Report Date
    March 11, 2011
    Manufacturer
    DEPUY PINNACLE
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WENT INTO THE HOSPITAL FOR HIP REVISION SURGERY (B)(6) 2006. I RECEIVED A DEPUY PINNACLE. UPON WAKING UP FROM SURGERY IN THE RECOVERY ROOM I TOLD MY WIFE SOMETHING WENT WRONG AND WAS HURTING BEYOND BELIEF. I HAD ALREADY HAD OTHER HIP REPLACEMENTS AND KNEW HOW I SHOULD HAVE FELT. I HAD TO HAVE IN HOSPITAL REHABILITATION FOR THE 1ST TIME. I KEPT TELLING MY ORTHOPAEDIC DOCTOR FROM DAY ONE AND FOR 7 MONTHS AFTER SURGERY THAT THERE WAS SOMETHING WRONG. HE JUST KEPT TELLING ME TO GIVE IT 6 MORE WEEKS. I FINALLY WENT TO ANOTHER ORTHOPAEDIC DOCTOR AND WAS TOLD THE HIP WAS INFECTED AND THE DEVICE NEVER ADHERED TO THE BONE AND WAS LOOSE. I HAD TO HAVE ALL PROSTHETICS REMOVED INCLUDING THE FEMUR ROD AND THEY PLACED AN ANTIBIOTIC BALL IN MY HIP FOR 3 MONTHS. I THEN HAD ANOTHER FULL HIP REPLACEMENT (B)(6) 2008. THIS TIME ZIMMER MANUFACTURER. UPON COMING OUT OF SURGERY (B)(6) 2008 I HAD DROP FOOT AND PERIPHERAL NERVE DAMAGE. I AM IN SEVERE PAIN AND STILL CAN NOT MOVE MY TOES OR WALK CORRECTLY. I AM NOW EXPERIENCING SIGNIFICANT PAIN IN THE GROIN, HIP AND THIGH AREA. I AM IN THE PROCESS NOW OF REQUESTING INFO TO SEE IF THE CURRENT PROSTHESIS IS PART OF THE ZIMMER DUROM CUP RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY HIP SUPPLIES KWA DEPUY PINNACLE PINNACLE YGID11000

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R