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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR DYSPLASIA CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR DYSPLASIA CUP 56MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74122256
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Failure of Implant (1924); Pain (1994); Toxicity (2333)
Date of Event 09/15/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that left hip revision surgery was performed due to pain and metallosis.
 
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Brand Name
BHR DYSPLASIA CUP 56MM
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 Key6878281
Report Number3005975929-2017-00294
Device Sequence Number13804310
Product Code NXT
UDI-Device Identifier03596010552372
UDI-Public03596010552372
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
P040033
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 05/02/2018
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 Date06/30/2012
Device Catalogue Number74122256
Device Lot Number07FW11293
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 09/15/2017
Supplement Date Received by Manufacturer09/15/2017
Initial Report FDA Received Date09/20/2017
Supplement Report FDA Received Date05/02/2018
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
DISTAL CENTRALISER, # 71313103, LOT # 08HM05848; DYSPLASIA SCREW, # 74500028, LOT #07ET08660; DYSPLASIA SCREW, # 74500052, LOT # 06MT04828; FEMORAL STEM, # 71312102, LOT # 09MT37837; MODULAR HEAD, # 74222148, LOT # 08GW17795; MODULAR SLEEVE, # 74222100, LOT # 08GW17831
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age71 YR
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