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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 10MM; 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 10MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL Back to Search Results
Catalog Number 74027232
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 10/30/2014
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient needed revision surgery due to arthrofibrosis.
 
Additional Manufacturer Narrative
Acknowledgment and first request letter was sent and attached.(b)(4).
 
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Brand Name
JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM
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 Key7070746
Report Number1020279-2017-01159
Device Sequence Number10999126
Product Code JWH
UDI-Device Identifier00885556179062
UDI-Public00885556179062
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source study,user facility
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 Expiration Date06/05/2023
Device Catalogue Number74027232
Device Lot Number13FM04801
Initial Date Received by Manufacturer 11/16/2017
Supplement Date Received by Manufacturer11/16/2017
Initial Report FDA Received Date11/30/2017
Supplement Report FDA Received Date02/19/2018
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 Required Intervention;
Patient Age54 YR
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