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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS INC. BIOMET M2A-MAGNUM TOTAL HIP IMPLANTS BIOMET TOTAL HIP IMPLANTS

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BIOMET ORTHOPEDICS INC. BIOMET M2A-MAGNUM TOTAL HIP IMPLANTS BIOMET TOTAL HIP IMPLANTS Back to Search Results
Model Number 11-173666
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Swelling (2091); Tissue Damage (2104)
Event Date 09/12/2011
Event Type  Injury  
Event Description

Pt had failure of metal-on-metal total hip with pain swelling and subluxation of components with pseudo-tumor one yr after original implantation, requiring removal of components. Extensive soft tissue damage.

 
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Brand NameBIOMET M2A-MAGNUM TOTAL HIP IMPLANTS
Type of DeviceBIOMET TOTAL HIP IMPLANTS
Manufacturer (Section D)
BIOMET ORTHOPEDICS INC.
po box 587
warsaw IN 46581 058
MDR Report Key2655985
MDR Text Key19997312
Report NumberMW5026145
Device Sequence Number2
Product Code KWA
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/10/2012
3 DeviceS WERE Involved in the Event: 1   2   3  
1 Patient Was Involved in the Event
Date FDA Received07/10/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number11-173666
Device Catalogue Number11-173666
Device LOT Number990050
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 07/10/2012 Patient Sequence Number: 1
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