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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE MED 7-8 RT 8MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
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SMITH & NEPHEW, INC. JRNY II XR INS XLPE MED 7-8 RT 8MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY Back to Search Results
Model Number 74023770
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Injury (2348)
Date of Event 06/19/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient suffered from right knee effusion and hemarthrosis.The event was treated via ablation and arthroscopy.
 
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Brand Name
JRNY II XR INS XLPE MED 7-8 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 Key9900936
Report Number1020279-2020-01054
Device Sequence Number2827907
Product Code JWH
UDI-Device Identifier00885556613153
UDI-Public00885556613153
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K152726
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/22/2020
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 Date01/01/2026
Device Model Number74023770
Device Catalogue Number74023770
Device Lot Number16AM00646
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/05/2020
Supplement Date Received by Manufacturer11/17/2020
Initial Report FDA Received Date03/30/2020
Supplement Report FDA Received Date11/22/2020
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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