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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT 9; PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR
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SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT 9; PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR Back to Search Results
Model Number 74023251
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Injury (2348)
Date of Event 02/26/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that revision surgery had to be performed 9 years after primary surgery due to the breakage of the post off of journey art ins bcs standard 5-6 right 9.The reason for the wreckage is not known.
 
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Brand Name
JOURN ART INS BCS STD 5-6 RT 9
Common Device Name
PRSTHSIS, KEE, PTLLOFEMROTIBIL, SMI-CONSTRIND, CMNTD, PLY/MTL/POLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9824719
Report Number1020279-2020-00852
Device Sequence Number3068035
Product Code JWH
UDI-Device Identifier03596010555137
UDI-Public03596010555137
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K042515
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2020
Reporter Type Manufacturer
Report Source consumer,user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 01/19/2021
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 Date11/04/2019
Device Model Number74023251
Device Catalogue Number74023251
Device Lot Number09DM08269
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2021
Initial Date Received by Manufacturer 02/26/2020
Supplement Date Received by Manufacturer01/14/2021
Initial Report FDA Received Date03/12/2020
Supplement Report FDA Received Date01/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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