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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH AND NEPHEW ANTHOLOGY FEMORAL COMPONENT BIRMINGHAM SYSTEM
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SMITH AND NEPHEW ANTHOLOGY FEMORAL COMPONENT BIRMINGHAM SYSTEM Back to Search Results
Lot Number 06AM02738B
Device Problems Metal Shedding Debris (1804); Noise, Audible (3273)
Patient Problems Toxicity (2333); Ambulation Difficulties (2544); Test Result (2695)
Event Date 02/11/2006
Event Type  Injury  
Event Description

Total hip replacement (b)(6) 2005. (b)(6) months later, hip joint begins clunking, and i experienced difficulty in walking. This has been a 4 year nightmare. I have had tests, been to other doctors and surgeons. Finally, this past (b)(6) 2011, i saw dr. (b)(6) in (b)(6). After bloodwork and aspiration of the hip, i have metallosis and am scheduled for a revision on (b)(6). Not a day too soon. I can hardly walk and experience pain almost every day. My hip, a smith and nephew has not been recalled yet, so the entire expense of this surgery is on me. I lost my insurance coverage when the premiums went through the roof and i could no longer afford it ((b)(6) per year). When i tried to get cheaper coverage, i was denied because of my hip. I always had health insurance. I was a (b)(6), but now i cannot work. I contacted an attorney and was informed that the hip i have is exempt because it was approved by you, the fda. The hip is a birmingham anthology femoral component, bhr acetabular cup, modular femoral head, and modular head sleeve. Please tell me what to do next, and what, if any recourse i have. I am.

 
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Brand NameANTHOLOGY FEMORAL COMPONENT
Type of DeviceBIRMINGHAM SYSTEM
Manufacturer (Section D)
SMITH AND NEPHEW
MDR Report Key2650971
MDR Text Key21022937
Report NumberMW5026075
Device Sequence Number1
Product Code NXT
Combination Product (Y/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 07/05/2012
4 DeviceS WERE Involved in the Event: 1   2   3   4  
1 Patient Was Involved in the Event
Date FDA Received07/05/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device LOT Number06AM02738B
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 07/05/2012 Patient Sequence Number: 1
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