BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE SECTOR II ACETABULAR CUP 54MM W METAL

    MDR report key: 1953711 · Received January 4, 2011

    Report

    Report Number
    MW5018894
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    April 13, 2011
    Report Date
    January 4, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM REPORTER (B)(6) 2011: METAL ON METAL HIP IMPLANT LESS THAN 5 YEARS, HIGH COBALT / HIGH CHROMIUM IN BLOOD HAS CAUSED ISSUES THROUGH OUT BODY. HEADACHES, EARS RINGING, NOSE BLEEDS, SNEEZING, VERTIGO, FATIGUE, DIZZINESS, WEIGHT GAIN, DEPRESSION, IRRITABILITY, DIARRHEA, TINGLING/BURNING IN BOTH HANDS, FINGERS, AND FEET, NUMBNESS TOES, TRIPPING OVER TOES, FOOD INTOLERANCE/ALLERGIES WORSE THAN EVER, ITCHING AT INCISION SITE AND LEGS, IMMEDIATE AND SHORT TERM MEMORY PROBLEMS, ATTENTION STICKING TO TASK, ESOPHAGUS SPASMS, SHORTNESS OF BREATH, FEEL LIKE I'M INHALING SULFUR BUT IT COMES FROM INSIDE ME, RESPIRATORY ISSUES, TERRIBLE HACKING COUGH - WON'T STOP, CAN'T CONTROL, LOSE CONTROL OF ALL BODY FUNCTION, URINARY SYSTEM - COMPLETE LEAK, WEIRD CHEST PAINS, TIGHTNESS, PRESSURE, HEART PALPITATIONS, HEART FLUTTERING, HORRIBLE GASTROINTESTINAL UPSETS/UP TO BREASTBONE, VISION PROBLEMS, SLEEPLESSNESS, SKIN/FACE BREAK OUTS WEIRD UNDER SKIN PUS LIKE, ABNORMAL EKG'S - STARTED YEAR AFTER HIP REPLACED, JOINT PAIN, KNEE ISSUES, SWELLING AT ANKLES.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 2/28/2014: F/U TO ORIGINAL REPORT ACCESS #(B)(4) ORIGINAL HIP REMOVED (B)(6) 2011, 3 YR F/U BLOOD TEST, STILL TOXIC METAL IN BLOOD.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED (B)(4) 2013: ACCESS NUMBER: MW5018894. UPDATE TO ORIGINAL REPORT, BLOOD STILL TOXIC 2 YRS AFTER ORIGINAL METAL ON METAL HIP REPLACED.

    Description of Event or Problem · 1

    VERY HIGH LEVELS OF METAL IN BLOOD.

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM REPORTER. ACCESS NUMBER (B)(4). ON (B)(6) 2011, MOM IMPLANT REMOVED, RIGHT BEFORE SURGERY, DOCTOR TOLD ME AFTER DISCUSSING WITH OTHER DOCTORS, HE WASN'T GOING TO REMOVE CUP, JUST REPLACE LINER AND BALL, I WAS CONCERNED. DURING SURGERY, COULD NOT GET LINER OUT, HAD TO REMOVE ENTIRE CUP WITH LINER, SEVERE METALLOSIS BEHIND CUP PLUS IN SURROUNDING TISSUE, SCREWS AND CUP TOTALLY CORRODED. SURGERY TOOK OVER 6 HOURS, RACING HEART ISSUES WHILE IN HOSPITAL, HAD BLOOD TRANSFUSIONS, STAYED ADDITIONAL NIGHT IN HOSPITAL DUE TO FEVER. SKIN BLISTERING FROM ADHESIVE. NOT ALLOWED UP WITHOUT BRACE AND WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE SECTOR II ACETABULAR CUP 54MM W METAL METAL ON METAL HIP PROSTHESIS KWA DEPUY ORTHOPAEDICS PINNACLE SECTOR II AV1BP1000
    2 DEPUY ARTICUL/EZE MOM FEMORAL HEAD 36M METAL ON METAL HIP PROSTHESIS KWA DEPUY ORTHOPAEDICS DEPUY ARTICUL/EZE MOM 2149626
    3 DEPUY SUMMIT TAPERED HIP STEM METAL ON METAL HIP PROSTHESIS LWJ DEPUY ORTHOPAEDICS DEPUY SUMMIT AK3C21000
    4 DEPUY PINNACLE CANCELLOUS BONE SCREW METAL ON METAL HIP PROSTHESIS HWC DEPUY ORTHOPAEDICS DEPUY PINNACLE Z6CBJ4000
    5 DEPUY PINNACLE CANCELLOUS BONE SCREW METAL ON METAL HIP PROSTHESIS HWC DEPUY ORTHOPAEDICS DEPUY PINNACLE Z3FA54000
    6 DEPUY APEX HOLE ELIMINATOR METAL ON METAL HIP PROSTHESIS LPH DEPUY ORTHOPAEDICS DEPUY APEX AT2AW1000

    Patients

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