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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIRMINGHAM HIP RESURFACING SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL RESURFACING

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SMITH & NEPHEW, INC. BIRMINGHAM HIP RESURFACING SYSTEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL RESURFACING Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 10/24/2019
Event Type  Injury  
Event Description
Reporter alleges she experienced excruciating pain and was advised by the pain institute to have her hips checked.Blood tests for metals was done on (b)(6) 2019 and the test showed high levels of carbide in her blood (about 3.9).She saw her physician on (b)(6) 2019 who advised she needs a revision to take out the implants and have a total hip replacement.She has been getting injections and is scheduled to explant right hip on (b)(6) 2020 and left hip on (b)(6) 2020.She was also informed the implants have deteriorated and if a revision is not done, she might need to use a wheel chair.Reporter is upset she has to go through this again and said she is aware the device has been recalled but the mfr has not notified her.Reporter has had a name change from stokes to kamp.
 
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Brand Name
BIRMINGHAM HIP RESURFACING SYSTEM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW, INC.
MDR Report Key9544014
MDR Text Key173745037
Report NumberMW5092020
Device Sequence Number2
Product Code NXT
Combination Product (y/n)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 01/02/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
Patient Weight113
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