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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. DEPUY PINNACLE METAL-ON-METAL TOTAL HIP REPLACEMENT

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DEPUY ORTHOPAEDICS, INC. DEPUY PINNACLE METAL-ON-METAL TOTAL HIP REPLACEMENT Back to Search Results
Event Date 11/30/2010
Event Type  Injury  
Event Description

Pt had to have revision hip replacement surgery to remove a metal-on-metal total hip implant which had caused significant synovial inflammation and metallosis reaction. The implant was a depuy pinnacle metal-on-metal hip replacement system -not the recalled asr system-. Dates of use: (b)(6) 2003 - (b)(6) 2010. Diagnosis or reason for use: hip arthritis. Event abated after use: yes. This is to report a significant problem with complications due to metal-on-metal wear particles leading to a pt necessitating revision hip surgery and removal of implants due to severe synovitis and perivascular lymphocytic infiltrate, confirmed with tissue pathology. The relevance is that this is a different product within the same company -depuy orthopaedics- which has recently had a different metal-on-metal hip implant recalled by the fda - the asr hip system-. This is to report a problem with their pinnacle metal-on-metal system. The common factor being the metal-on-metal bearing, leading to metal particulate release, and significant synovial reaction, and necessitating revision surgery and implant removal. Patients should be made aware of the significant risk associated with this system.

 
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Brand NameDEPUY PINNACLE METAL-ON-METAL TOTAL HIP REPLACEMENT
Type of DeviceDEPUY PINNACLE METAL-ON-METAL TOTAL HIP REPLACEMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw IN 46582
MDR Report Key1932627
Report NumberMW5018602
Device Sequence Number1
Product CodeLPH
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/14/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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: 12/14/2010 Patient Sequence Number: 1
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