MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP RT SZ 4; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR

Catalog Number	74022214
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Swelling (2356)
Date of Event	10/07/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a total knee arthroplasty was performed on the right knee for patellar component and poly exchange due to knee pain, leg pain, associated swelling and loosening of internal prosthesis right knee.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.[(b)(4)].

• Brand Name: JOURNEY TIBIA BASE NP RT SZ 4
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7035675
• Report Number: 1020279-2017-01033
• Device Sequence Number: 13491800
• Product Code: JWH
• UDI-Device Identifier: 03596010554284
• UDI-Public: 03596010554284
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2018

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: 06/21/2024
• Device Catalogue Number: 74022214
• Device Lot Number: 14FM16780
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 11/06/2017; 11/06/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 11/30/2017; 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 85