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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 3-4-RT 11MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL
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SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 11MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL Back to Search Results
Catalog Number 74027233
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 08/04/2014
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that, after a knee replacement, a patient had knee effusion, tricompartmental synovitis with hypertrophic scar and lateral bone spur, and plica syndrom.
 
Additional Manufacturer Narrative
Please review attached for the investigation results.
 
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Brand Name
JRNY II BCS XLPE ART ISRT SZ 3-4-RT 11MM
Common Device Name
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7116641
Report Number1020279-2017-01253
Device Sequence Number19188173
Product Code JWH
UDI-Device Identifier00885556179116
UDI-Public00885556179116
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/19/2018
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 Catalogue Number74027233
Device Lot Number12AM15819
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/01/2017
Supplement Date Received by Manufacturer12/01/2017
Initial Report FDA Received Date12/14/2017
Supplement Report FDA Received Date02/19/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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