MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY II UNI TIBIA XLPE INSERT SIZE 3-4 11MM LM/RL; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71935212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/26/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the clinical subject experienced pain following the surgery, the event was treated via medication.On (b)(6) 2021 subject had a revision surgery.Subject outcome is unknown.

• Brand Name: JOURNEY II UNI TIBIA XLPE INSERT SIZE 3-4 11MM LM/RL
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 7000 west william cannon drive; austin TX
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX ; 5123913905
• MDR Report Key: 12303495
• Report Number: 1020279-2021-06264
• Device Sequence Number: 3668647
• Product Code: HSX
• UDI-Device Identifier: 00885556578919
• UDI-Public: 00885556578919
• Combination Product (Y/N): N
• PMA/510(K) Number: K152315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71935212
• Device Catalogue Number: 71935212
• Device Lot Number: 16DAP4566A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/15/2020
• Supplement Date Received by Manufacturer: 09/15/2021; 10/24/2022
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/15/2021; 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown