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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET, INC. LEFT HIP REPLACEMENT; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
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BIOMET, INC. LEFT HIP REPLACEMENT; PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) Back to Search Results
Device Problems Nonstandard Device (1420); Defective Component (2292)
Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Swelling (2091); Toxicity (2333)
Event Date 04/10/2019
Event Type  Injury  
Event Description
Pain off and on since original hip replacement in 2003.Started severe pain down incision scar followed with huge boil like place, hot to touch, red, constant pain, and running fever.Took until (b)(6) 2019 to see my orthopedist.He immediately drained infection, sent off for testing and was immediately transferred to (b)(6)."dr (b)(6)." metal poisoning from recalled prosthesis and i was never notified.Biomet prosthesis, having to have 1st surgery with an antibiotic spacer for 6 wks, then to follow a complete hip revision.Staying in constant pain, incision draining and bandage changed throughout the day.Running fever not over 101.Not my fault that it has taken this long or my body to get this infected into the bone.No one notified me of recalled defective prosthesis, and i should have been informed.I have gone through hell for the last 4 months, and have a long, extensive, and long recovery ahead of me.Biotech should be liable.
 
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Brand Name
LEFT HIP REPLACEMENT
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT)
Manufacturer (Section D)
BIOMET, INC.
MDR Report Key8683446
MDR Text Key147594392
Report NumberMW5087221
Device Sequence Number0
Product Code KWA
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 05/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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) Hospitalization; Other; Required Intervention; Disability;
Patient Age46 YR
Patient Weight40
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