FDA Adverse Event Death Summary report: N

BIOMET MAGNUM CHROMIUM COBALT

MDR report key: 3535834 · Received December 18, 2013

Report

Report Number
MW5033564
Event Type
Death
Date Received
December 18, 2013
Report Date
December 17, 2013
Manufacturer
BIOMET
Product Code
KWA
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY HUSBAND REC'D A MOM HIP REPLACEMENT (BIOMET MAGNUM) 2009. SIX MONTHS OR LESS, HE WAS STILL HAVING PAIN AND BURSITIS W/ FLUID. OVER THE COURSE OF A YR, MY HUSBAND STARTED HAVING SYMPTOMS OF FATIGUE, FEELING UNWELL, GAIT WAS OFF/STILL HAD PAIN. SECOND AND THIRD YR SYMPTOMS WORSENED, FELT LIKE HIP WAS OUT OF PLACE, BUT WASN'T FATIGUE, VISION WORSENED, HEARING WORSENED, MEMORY AND THINKING SKILLS WORSENED. HE WAS GOING TO RECEIVE ANOTHER HIP AND DURING PRE-OP, THEY FOUND NECROTIC TISSUE ON LUNG WHICH WAS REMOVED; HE PRETTY MUCH HAD ALL SYMPTOMS OF METALLOSIS. SEVEN MONTHS LATER, HIS VISION, HEARING, AND COGNITIVE SKILLS WORSENED, SWALLOWING PROBLEMS, AND SLURRED SPEECH. HE SOMEHOW DEVELOPED A RARE FORM OF NEUROENDOCRINE CARCINOMA, JUST IN LIVER AND BRAIN NO WHERE ELSE. WITHIN A THREE WEEK PERIOD AFTER LAST SCAN, IT EXPLODED IN HIS BODY TO THE PANCREAS, ADRENAL GLANDS, KIDNEYS, BONES, AND FATTY TISSUE IN ABDOMEN WHICH COULD NOT BE EXPLAINED. THAT HAPPENED DURING RADIATION TREATMENT. IN ALL THE REPORTS, I'VE SEEN A LOT OF REPORTS THAT DNA CAN CHANGE TO CANCEROUS CELLS WHICH I THINK HAPPENED TO MY HUSBAND. I THINK THE MOM HIP REPLACEMENTS CAUSED HIS ILLNESS. HE WAS A VERY HEALTHY PERSON UNTIL HE REC'D THIS HIP. HE ALWAYS SAID HE THOUGH IT WAS THE CAUSE BECAUSE HE HASN'T FELT RIGHT SINCE HE GOT IT AND HAS HAD HEALTH ISSUES SINCE. HE PASSED AWAY DUE TO THREE DIFFERENT BATTLES WITH SEPSIS AFTER HE HAD A BILIARY STENT PLACED DUE TO A BLOCKAGE. THE SEPSIS ENCOUNTERS HAPPENED WELL AFTER THE CHEMO AND HE WAS NOT LEUKOPENIA OR NEUTROPENIA. HE ALSO DEVELOPED WEAKENING OF THE HEART HAD UNEXPLAINED INFECTIONS AND SEPSIS. THE FDA NEEDS TO TAKE A CLOSER LOOK AT THE EFFECTS THESE HAVE ON INDIVIDUALS TO POSSIBLY TAKE THEM OFF THE MARKET AND DOCTORS NEED TO MONITOR BETTER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
661721 BIOMET MAGNUM CHROMIUM COBALT BIOMET MAGNUM CHROMIUM COBALT KWA BIOMET

Patients

Seq Age Sex Outcome Treatment
1 47 YR Death| H| L| S