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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW INC. BIRMINGHAM HIP RESURFACING IMPLANT 12-072 CMH

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SMITH & NEPHEW INC. BIRMINGHAM HIP RESURFACING IMPLANT 12-072 CMH Back to Search Results
Event Date 05/03/2011
Event Type  Injury  
Event Description

On (b)(6), 2007 (b)(6) had a birmingham hip resurfacing implanted in his right hip. On (b)(6), 2011 he developed an infection around hip site. He was admitted to (b)(6) hospital where it was surgically cleaned and he left hospital on iv antibiotics for six weeks. On (b)(6), 2011 (b)(6) was brought to emergency room and admitted again as infection returned. On (b)(6) 2011 (b)(6) again underwent surgery and had the implant removed and 8 weeks of iv antibiotics at home. A spacer was inserted. On (b)(6) 2011, (b)(6) was again admitted to (b)(6) for bloodclots in his legs as a result of not being mobile due to the spacer. He had a filter inserted and is awaiting one more surgery on (b)(6) 2011 to have a total hip replacement using ceramic and plastic not metal on metal like the nephew and smith birmingham one was. This prosthesis problem is very similar to the j&j depuy. Also the birmingham has had many recalls. It appears to be a problem when a healthy man after 4 years has all these issues arise. It is possible that pseudotumors developed due to metal on metal rubbing together. Was the metal debris released into the bloodstream? these seems too coincidental to the depuy case.

 
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Brand NameBIRMINGHAM
Type of DeviceHIP RESURFACING IMPLANT 12-072 CMH
Manufacturer (Section D)
SMITH & NEPHEW INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key2381369
Report NumberMW5023470
Device Sequence Number1
Product CodeNXT
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 12/13/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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: 12/13/2011 Patient Sequence Number: 1
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