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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 5-6 RT 8MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
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SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 5-6 RT 8MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY Back to Search Results
Model Number 74023850
Medical Device Problem Code Physical Resistance/Sticking (4012)
Health Effect - Clinical Code Injury (2348)
Date of Event 08/01/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient was diagnosed with left knee stiffness.The event was resolved via manipulation under anesthesia.
 
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Brand Name
JRNY II XR INS XLPE LAT 5-6 RT 8MM
Common Device Name
PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9900952
Report Number1020279-2020-01060
Device Sequence Number11470108
Product Code JWH
UDI-Device Identifier00885556613177
UDI-Public00885556613177
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K152726
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/01/2020
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 Expiration Date02/26/2026
Device Model Number74023850
Device Catalogue Number74023850
Device Lot Number16BM20521
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/03/2020
Supplement Date Received by Manufacturer11/22/2020
Initial Report FDA Received Date03/30/2020
Supplement Report FDA Received Date12/01/2020
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 Age56 YR
Patient Weight95
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