MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 4; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL

Catalog Number	74022214
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	05/11/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a knee aspiration was performed due to increased swelling with hematoma.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached for the results of our investigation.

• Brand Name: JOURNEY TIBIA BASE NP RT SZ 4
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7134957
• Report Number: 1020279-2017-01308
• Device Sequence Number: 18853419
• Product Code: JWH
• UDI-Device Identifier: 03596010554284
• UDI-Public: 03596010554284
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2018

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 Date: 07/14/2023
• Device Catalogue Number: 74022214
• Device Lot Number: 13GM10557
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 02/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR