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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; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
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SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 5-6 RT 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, Back to Search Results
Model Number 74023850
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Loss of Range of Motion (2032)
Date of Event 05/30/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported, after a tka surgery had been performed in which a journey ii cr lateral insert was implanted, the clinical subject presented stiffness in the right knee.It cannot be excluded that the adverse event is linked to the surgery.The event was resolved with manipulation under anesthesia.
 
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Brand Name
JRNY II XR INS XLPE LAT 5-6 RT 8MM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key10043927
Report Number1020279-2020-01576
Device Sequence Number17106760
Product Code JWH
UDI-Device Identifier00885556613177
UDI-Public00885556613177
Combination Product (Y/N)N
Initial Reporter StateOR
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 Physician
Type of Report Initial,Followup
Report Date (Section B) 12/14/2020
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 04/14/2020
Supplement Date Received by Manufacturer12/09/2020
Initial Report FDA Received Date05/11/2020
Supplement Report FDA Received Date12/14/2020
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 Required Intervention;
Patient Age57 YR
Patient Weight103
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