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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 50MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74120150
Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Date 02/11/2019
Event Type  Injury  
Event Description
Revision surgery was performed due to pain.Devices were implanted 10-11 years ago.
 
Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21cfr, part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
 
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Brand Name
BHR ACETABULAR CUP 50MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
MDR Report Key8349429
MDR Text Key136460005
Report Number3005975929-2019-00073
Device Sequence Number1
Product Code NXT
UDI-Device Identifier03596010502568
UDI-Public03596010502568
Combination Product (y/n)N
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/31/2011
Device Catalogue Number74120150
Device Lot Number66669 015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2019
Date Manufacturer Received02/11/2019
Patient Sequence Number1
Treatment
FEMORAL HEAD, # 74121142, LOT # 66989; FEMORAL HEAD, # 74121142, LOT # 66989 034; FEMORAL HEAD, # 74121142, LOT # 66989
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age56 YR
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