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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE - DJO SURGICAL ENCORE MEDICAL METAL ON METAL HIP PROSTHETIC HIP

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ENCORE - DJO SURGICAL ENCORE MEDICAL METAL ON METAL HIP PROSTHETIC HIP Back to Search Results
Model Number METAL ON METAL ENCORE
Event Type  Other  
Event Description

Swelling pain, and decreased mobility with increased blood serum cobalt. Since total hip replacement (2004 pt. (b)(6)) with encore (now djo surgical) metal on metal hip, have had increasing pain, and swelling requiring occasional narcotic pain control medications. Continued and frequent pain and swelling at this point, elevated serum cobalt 10. 3.

 
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Brand NameENCORE MEDICAL METAL ON METAL HIP
Type of DevicePROSTHETIC HIP
Manufacturer (Section D)
ENCORE - DJO SURGICAL
MDR Report Key2296530
Report NumberMW5022605
Device Sequence Number1
Product CodeKWA
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/10/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/10/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMETAL ON METAL ENCORE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 10/10/2011 Patient Sequence Number: 1
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