MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY TIBIA BASE NP LT SZ 5; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY

Catalog Number	74022225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	06/12/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery (flush and poly exchange) due to patient's knee infection.
Additional Manufacturer Narrative
Other components involved in this event have been communicated through mdrs: 1020279-2017-01013 , 1020279-2017-01113 and 1020279-2017-01112.This report adds information under b5 correcting in part the previosly provided narrative.(b)(4).
Event or Problem Description
Further on it was clarified that patient underwent total knee exchange with revision of all components, rather than just the poly.

• Brand Name: JOURNEY TIBIA BASE NP LT SZ 5
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7057905
• Report Number: 1020279-2017-01114
• Device Sequence Number: 900936
• Product Code: JWH
• UDI-Device Identifier: 03596010554338
• UDI-Public: 03596010554338
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

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: 02/03/2019
• Device Catalogue Number: 74022225
• Device Lot Number: 09BM04206
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/24/2017
• Supplement Report FDA Received Date: 02/21/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 52 YR