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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW BIRMINGHAM HIP RESURFACING
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SMITH & NEPHEW BIRMINGHAM HIP RESURFACING Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); Rash (2033); Depression (2361); Disability (2371); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 11/19/2014
Event Type  Injury  
Event Description
Had bhr (smith & nephew) implanted in 2007.After third dislocation hospitalized for 9.5 months, continue to have rashes, pain, back problems occurring etc.Had revision surgery as recent as (b)(6) 2014.Aspirated fluids.Surgeon replaced ball and stem for fear of infection recurring.Have been on pain med for months.Need a walker and custom shoe in order to walk, as leg length was 6+ inch difference when bhr removed.New hip implanted left a 3+ inch difference in leg length.I exercise, trying to preserve my health and beginning new therapy.My work has been compromised due to physical disabilities and mental ability, continue to have low grade temperatures.Majority of these issues are a result from the original bhr implant.I continue to have health issues.
 
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Brand Name
BIRMINGHAM HIP RESURFACING
Type of Device
BIRMINGHAM HIP RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW
MDR Report Key4280477
MDR Text Key21178714
Report NumberMW5039266
Device Sequence Number1
Product Code NXT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/19/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/20/2014
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age62 YR
Patient Weight78
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