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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 RT15; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 RT15; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 74023255
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code Pain (1994)
Date of Event 11/14/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient crossed his legs and felt pain about a month ago.It was determined that the post of the insert had fractured and a right knee revision surgery was performed to exchange the insert.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.[(b)(4)].
 
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Brand Name
JOURN ART INS BCS STD 5-6 RT15
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7028379
Report Number1020279-2017-01023
Device Sequence Number13762734
Product Code JWH
UDI-Device Identifier03596010555175
UDI-Public03596010555175
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K042515
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/13/2018
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 Date03/28/2016
Device Catalogue Number74023255
Device Lot Number06CM00343
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/14/2017
Supplement Date Received by Manufacturer11/14/2017
Initial Report FDA Received Date11/14/2017
Supplement Report FDA Received Date02/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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