BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNUM, METAL ON METAL COBALT CHROMIUM

    MDR report key: 3052826 · Received April 7, 2013

    Report

    Report Number
    MW5029695
    Event Type
    Injury
    Date Received
    April 7, 2013
    Date of Event
    October 10, 2012
    Report Date
    April 7, 2013
    Manufacturer
    BIOMET
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2006 AND 2007, PT HAD A BIOMET MAGNUM METALON METAL COBALT CHROMIUM HIP IMPLANTED, HIS LEFT LEG WAS IN 2006 AND HIS RIGHT IN 2007. DATING AT LEAST BACK IN (B)(6) 2012, HE WAS HAVING NONSPECIFIC SYMPTOMS OF FATIGUE, WEIGHT GAIN AND SHORTNESS OF BREATH. AN ECHOCARDIOGRAM DONE REVEALED A PRESERVED EJECTION FRACTION. HE THEN CONTINUED TO DETERIORATE MORE AND A REPEAT ECHOCARDIOGRAM WAS DONE WHICH REVEALED A REDUCED EJECTION FRACTION AT AN OUTSIDE FACILITY IN (B)(6) 2012. AT THAT TIME PT WAS READING ABOUT CASE REPORTS OF HIS HIP IMPLANT CAUSING ELEVATED COBALT LEVELS AND CHROMIUM LEVELS DUE TO METAL ON METAL INTERACTION AND SHAVINGS BEING SEEPED INTO THE BLOODSTREAM. HE HAD HIS CHROMIUM CHECKED IN OCTOBER AND THE LEVEL AT OUR HOSPITAL WAS 81.1, UPPER LIMIT OF NORMAL IS 2. HE ALSO HAD ELEVATED COBALT LEVELS DRAWN AT THAT TIME AND THE LEVEL WAS 189.4, ULN IS 0.9. THEY WERE NOT SURE, AT THE TIME, IF THE CARDIOMYOPATHY WAS DUE TO VALVULAR DISEASE OR OTHER ETIOLOGIES. HE HAD A LEFT HEART CATHETER WHICH REVEALED TO GET THE HIPS REMOVED SO HE PRESENTED TO (B)(6) TO OUR CLINIC IN (B)(6) 2013 TO BE EVALUATED FOR SECOND OPTION. HE HAD A TEE THAT REVEALED AN EF OF 30% IN (B)(6) 2013 AND A TTE IN (B)(6) 2013 THAT REVEALED AN EF OF 30-35%. HE HAD A CARDIAC MRI THAT SUGGESTED AN INFILTRATIVE CARDIOMYOPATHY. HE HAD A RIGHT HEART CATH THAT SAME MONTH AS WELL. HE UNDERWENT A RIGHT VENTRICLE BIOPSY THAT THE PATHOLOGY WAS CONSISTENT WITH COBALT CARDIOMYOPATHY THAT WAS PREVIOUSLY DESCRIBED IN THE LITERATURE. HE THEN UNDERWENT REPEAT RIGHT HEART CATH ON (B)(6) 2013 AND WAS STARTED ON IV MILRINONE. HE THEN WENT TO THE OPERATING ROOM ON (B)(6) 2013 AND HAD BOTH HIPS REMOVED AND NON-COBALT ONES PLACED. HIS MILRINONE IS IN THE PROCESS OF BEING WEANED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142255 MAGNUM, METAL ON METAL COBALT CHROMIUM HIP REPLACEMENT KWA BIOMET UNK
    142256 MAGNUM, METAL ON METAL COBALT CHROMIUM HIP REPLACEMENT KWA BIOMED UNK

    Patients

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