MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 RT 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	74027254
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Injury (2348); Joint Disorder (2373)
Date of Event	03/26/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent revision surgery due to complaining about synovitis, pain, inflammation and contracture of lower right leg.
Additional Manufacturer Narrative
Corrections based on new information provided.
Additional Manufacturer Narrative
Please review attached for investigation results.(b)(4).

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 5-6 RT 12MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6829614
• Report Number: 1020279-2017-00673
• Device Sequence Number: 59683
• Product Code: JWH
• UDI-Device Identifier: 00885556179512
• UDI-Public: 00885556179512
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2018

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: 10/31/2021
• Device Catalogue Number: 74027254
• Device Lot Number: 11LM02105
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 08/02/2017; 08/02/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 11/14/2017; 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JOURNEY TIBIA BASE NP RT SZ 5, (B)(4); JRNY BCS II FEMORAL OXIN RT SZ 5, (B)(4); JRNY BCS PAT RESRF RD 35 MM STD, (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 82