BEUDAMED
    FDA Adverse Event Death Summary report: N

    HIP IMPLANT

    MDR report key: 3283769 · Received August 8, 2013

    Report

    Report Number
    MW5031376
    Event Type
    Death
    Date Received
    August 8, 2013
    Date of Event
    August 6, 2013
    Report Date
    August 7, 2013
    Manufacturer
    BIO-MET
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) HAD BIO-MET HIP IMPLANT ON (B)(6) 2009. ON (B)(6) 2013, HE DIED AT (B)(6) FROM COBALT POISONING FROM HIP IMPLANT WHICH CAUSED CARDIOMYOPATHY, AND THE DEATH OF HIS HEART MUSCLE. THE COBALT LEVEL IN HIS BLOOD WAS 208 (IT SHOULD BE LESS THAN 1).

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM REPORTER (B)(6) 2013: MY HUSBAND (B)(6), HAD THE HIP IMPLANTED AT (B)(6) HOSPITAL IN (B)(6), ON (B)(6) 2009. PRIOR TO IMPLANT, HE WAS VERY HEALTHY. HE WAS EXPERIENCING PAIN IN HIS HIP DUE TO ARTHRITIS IN THAT JOINT ONLY. (B)(6) HAD HIGH TRIGLYCERIDES AND HIGH BLOOD PRESSURE, BOTH CONTROLLED BY MEDICATION. HE HAD NO HEART PROBLEMS OR OTHER HEALTH ISSUES. THE IMPLANT WAS EXTREMELY SUCCESSFUL AT ONSET; HE RESUMED NORMAL ACTIVITIES, INCLUDING DANCING, IN ABOUT 6 WEEKS. HE HAD NO COMPLICATIONS AT THAT TIME. YEARLY FOLLOW-UP OCCURRED AS SCHEDULED. IN (B)(6) 2012, (B)(6) NOTICED THE HIP WAS MAKING SQUEAKING NOISE WHEN HE WALKED. HE RETURNED TO THE DOCTOR, AND ALL APPEARED TO BE SATISFACTORY. HE WAS NOT EXPERIENCING ANY PAIN. IN (B)(6) 2012, THE SQUEAKING WAS LOUDER, AND HE BEGAN EXPERIENCING CLAUSTROPHOBIA, RESTLESSNESS, AND DIFFICULTY SLEEPING. ON (B)(6) 2012, HIS COBALT PLASMA BLOOD TEST WAS 95.2 AND HIS CHROMIUM TEST WAS 57.6. HE WAS STILL IN NO PAIN, SO NO ACTION WAS TAKEN. ON (B)(6) 2013, HE WAS ADMITTED TO (B)(6) FOR A PERICARDIAL EFFUSION. THEY DRAINED 1100 CC OF FLUID. HE WAS EXPERIENCING DIFFICULTY BREATHING WHEN LYING DOWN, OR DANCING. THERE WAS NO DIAGNOSIS AT THAT TIME. HIS HEART CONTINUED TO DETERIORATE, DESPITE REGULAR VISITS WITH A CARDIOLOGIST AT THE HOSPITAL. ON (B)(6) 2013, HIS SERUM BLOOD TEST FOR COBALT WAS OVER 100. AT THAT TIME, THE DIAGNOSIS OF CARDIOMYOPATHY DUE TO COBALT TOXICITY FROM THE HIP IMPLANT WAS MADE BY CARDIOLOGIST, DR (B)(6) OF (B)(6). ON (B)(6) 2013, HE WAS ADMITTED TO (B)(6) HOSP. ON (B)(6) 2013, HIS COBALT SERUM LEVEL WAS 208, AND HIP REMOVAL WAS RECOMMENDED, BUT HIS HEART WAS TOO WEAK, AND HE DEVELOPED AN INFECTION. ALL OF HIS ORGANS BEGAN TO FAIL. HE DEVELOPED GREEN VISION, GOUT, DIABETES, AND UNSTABLE BLOOD PRESSURE. EXTRAORDINARY MEASURES BEGAN. HE DEVELOPED AN ARTERIAL BLOOD CLOT IN HIS LEFT LEG, AND THEN HE WAS PLACED ON AN ECMO MACHINE. ON (B)(6) 2013, HE HAD BIVENTRICULAR ASSISTIVE DEVICE SURGERY BY CARDIOTHORACIC SURGEON, DR (B)(6), AT (B)(6). SHE REPORTED HIS HEART WAS WORSE THAN ANY SHE HAD EVER SEEN, AND THERE WAS NO MUSCLE TISSUE. A HEART MUSCLE TISSUE SAMPLE WAS TAKEN AND TESTED. INITIAL RESULTS WERE POSITIVE FOR METAL. HE NEVER REGAINED CONSCIOUSNESS AFTER SURGERY. THE MACHINES WERE DISCONNECTED AND HE WAS DECLARED DEAD ON (B)(6) 2013, AT (B)(6). AN AUTOPSY WAS PERFORMED AT (B)(6) ON (B)(6) 2013. THE RESULTS OF TISSUE TESTS FOR HEAVY METAL ARE STILL PENDING (8 WEEKS). AN INDEPENDENT AUTOPSY WAS DONE IN (B)(6), ON (B)(6) 2013, DURING WHICH THE HIP AND SOME TISSUE SURROUNDING IT, WERE RECOVERED. THOSE RESULTS ARE ALSO PENDING. THE DEATH CERTIFICATE FROM (B)(6) SAYS "BIVENTRICULAR CARDIOMYOPATHY." THE RESULTS OF THE TISSUE SAMPLES FROM THE AUTOPSY HAVE NOT YET BEEN RECEIVED, BUT THE RESULTS OF THE CARDIAC TISSUE TEST TAKEN AT THE TIME OF THE VAD SURGERY ON (B)(6) 2013, AT (B)(6) SHOULD BE AVAILABLE. I HOPE I HAVE COVERED ALL THE INFO YOU NEED FOR YOUR REPORT. IF YOU HAVE ANY FURTHER QUESTIONS, FEEL FREE TO CONTACT ME BY LETTER, TELEPHONE, OR EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375672 HIP IMPLANT HIP IMPLANT KWA BIO-MET
    375673 M2A MAGNUM HEAD 54 MM HEAD DIAMETER HEAD DIAMETER KWA BIOMET ORTHOPEDICS, INC 805800
    375674 M2A MAGNUM PF CUP 60 MM OD X 54 MM CUP KWA BIOMET ORTHOPEDICS, INC 748660
    375675 MOD TAPERLOC FEMORAL 12.5 X 145 MM FEMORAL TAPERLOC KWA BIOMET ORTHOPEDICS, INC 397850
    375676 M2A MAGNUM TAPER ADAPTER 52-60 MM HEAD TAPER ADAPTER HEAD KWA BIOMET ORTHOPEDICS, INC 832340

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H