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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR ACETABULAR CUP 48MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74120148
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994); Swelling (2091)
Date of Event 11/18/2015
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that right hip revision surgery was performed due to increasing pain and swelling with severe metal-metal reaction around the hip joint.
 
Additional Manufacturer Narrative
(b)(4).
 
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Brand Name
BHR ACETABULAR CUP 48MM
Common Device Name
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 Key6652847
Report Number3005975929-2017-00180
Device Sequence Number16513500
Product Code NXT
UDI-Device Identifier03596010502544
UDI-Public03596010502544
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P040033
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Device Explanted Year2015
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date (Section B) 07/20/2017
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
Operator of Device Health Professional
Device Expiration Date05/31/2013
Device Catalogue Number74120148
Device Lot Number087217
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/15/2017
Supplement Date Received by Manufacturer06/15/2017
Initial Report FDA Received Date06/20/2017
Supplement Report FDA Received Date07/20/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
FEMORAL HEAD, # 74121142, LOT # 079414
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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