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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR DYSPLASIA CUP 66MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD BHR DYSPLASIA CUP 66MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74120266
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Toxicity (2333)
Date of Event 07/28/2016
Type of Reportable Event Serious Injury
Event or Problem Description
Left hip revision surgery was performed due to pain.Postoperative diagnosis: metallosis, trunnion corrosion, psoas tendinitis.
 
Additional Manufacturer Narrative
(b)(4).
 
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Brand Name
BHR DYSPLASIA CUP 66MM
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 Key6685268
Report Number3005975929-2017-00190
Device Sequence Number998776
Product Code NXT
UDI-Device Identifier03596010502704
UDI-Public03596010502704
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P040033
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2016
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Patient
Type of Report Initial,Followup
Report Date (Section B) 03/02/2018
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 Date06/30/2013
Device Catalogue Number74120266
Device Lot Number089748
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/27/2017
Supplement Date Received by Manufacturer06/27/2017
Initial Report FDA Received Date07/04/2017
Supplement Report FDA Received Date03/02/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age58 YR
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