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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET, INC. BIOMET MOM MAGNUM; PROTHESIS, HIP, SEMI-CONSTRAINED
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BIOMET, INC. BIOMET MOM MAGNUM; PROTHESIS, HIP, SEMI-CONSTRAINED Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Vomiting (2144); Toxicity (2333)
Event Date 08/01/2009
Event Type  Injury  
Event Description
Had bilateral biomet mom implants in (b)(6) 2004 and (b)(6) 2005.Required to have revision surgery on one hip in (b)(6) 2016 and the 2nd hip in (b)(6) 2016.Astronomical metal levels in my blood causing nosebleeds, nausea/vomiting, migraines, unexplained weight loss and extreme memory loss.Even after both revisions and 2.5 years, still suffering with high metal levels, pain and memory loss.Lower metal levels than before revisions but nowhere near normal.Still suffering pain daily in both hips and surgeon now reluctant to go back in to remove metal ball because so much tissue had to be removed during the revisions.To remove tissue full of metal debris, he is afraid the joint area will be unstable.Biomet refuses to recall their product and they do not care what has happened to me.
 
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Brand Name
BIOMET MOM MAGNUM
Type of Device
PROTHESIS, HIP, SEMI-CONSTRAINED
Manufacturer (Section D)
BIOMET, INC.
MDR Report Key8074602
MDR Text Key127534397
Report NumberMW5081307
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/11/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age69 YR
Patient Weight68
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