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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 3-4 LT 8MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
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SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 3-4 LT 8MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY Back to Search Results
Model Number 74023840
Medical Device Problem Code Physical Resistance/Sticking (4012)
Health Effect - Clinical Code Injury (2348)
Date of Event 12/27/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient was diagnosed with left knee stiffness.The subject was hospitalized and manipulation under anesthesia was performed to resolve the issue with residual effects.
 
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Brand Name
JRNY II XR INS XLPE LAT 3-4 LT 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 Key9903366
Report Number1020279-2020-01102
Device Sequence Number16823940
Product Code JWH
UDI-Device Identifier00885556615652
UDI-Public00885556615652
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 health professional,study,use
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/07/2020
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 Number74023840
Device Catalogue Number74023840
Device Lot Number16LM12245
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/05/2020
Supplement Date Received by Manufacturer11/30/2020
Initial Report FDA Received Date03/31/2020
Supplement Report FDA Received Date12/07/2020
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;
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