MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 3-4 RT 8MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,

Model Number 74023830

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthralgia (2355); Joint Swelling (2356)

Event Date 02/08/2018

Event Type  Injury  

Event Description

It was reported, after a primary tka surgery had been performed with a journey ii system, the clinical subject experienced occasional swelling and pain.The implanted tkr system failed: it is believed that tibial loosening was implicated.A revision surgery was performed to explant the journey ii lateral insert.An s&n legion system was implanted instead.The event is considered as resolved.

• Brand Name: JRNY II XR INS XLPE LAT 3-4 RT 8MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED,
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 10027432
• MDR Text Key: 189973243
• Report Number: 1020279-2020-01482
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556615607
• UDI-Public: 00885556615607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 74023830
• Device Catalogue Number: 74023830
• Device Lot Number: 16FM09963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2020
• Date Device Manufactured: 06/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR