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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
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SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 74027271
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Codes Injury (2348); Joint Disorder (2373)
Date of Event 04/18/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the patient presented with medio-lateral instability.The patient underwent a right knee revision surgery to exchange the insert.
 
Additional Manufacturer Narrative
(b)(4).
 
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Brand Name
JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7068102
Report Number1020279-2017-01139
Device Sequence Number67696
Product Code JWH
UDI-Device Identifier00885556179710
UDI-Public00885556179710
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
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) 02/23/2018
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 Date10/14/2023
Device Catalogue Number74027271
Device Lot Number13KM11864
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/30/2017
Supplement Date Received by Manufacturer10/30/2017
Initial Report FDA Received Date11/29/2017
Supplement Report FDA Received Date02/23/2018
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;
Patient Weight99
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