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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 1-2 LT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY
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SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 1-2 LT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY Back to Search Results
Model Number 74023822
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 12/19/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient presented patellar impingement on the left knee.The event was treated with an arthroscopic synovectomy.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand Name
JRNY II XR INS XLPE LAT 1-2 LT 10MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLY/MET/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key10012454
Report Number1020279-2020-01404
Device Sequence Number3303516
Product Code JWH
UDI-Device Identifier00885556615577
UDI-Public00885556615577
Combination Product (Y/N)N
Initial Reporter StateNV
Initial Reporter CountryUS
PMA/510(K) Number
K152726
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/09/2020
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 Model Number74023822
Device Catalogue Number74023822
Device Lot Number16LM10098
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/06/2020
Supplement Date Received by Manufacturer12/03/2020
Initial Report FDA Received Date04/29/2020
Supplement Report FDA Received Date12/09/2020
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 Weight63
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