MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 15MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY

Catalog Number	74027266
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 patients knee infection.
Additional Manufacturer Narrative
Other components involved in this event have been communicated through mdrs: 1020279-2017-01114 , 1020279-2017-01113 and 1020279-2017-01013.[(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: JRNY II BCS XLPE ART ISRT SZ 5-6 LT 15MM
• 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: 7057906
• Report Number: 1020279-2017-01112
• Device Sequence Number: 944977
• Product Code: JWH
• UDI-Device Identifier: 00885556178218
• UDI-Public: 00885556178218
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K111711
• 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: 08/06/2022
• Device Catalogue Number: 74027266
• Device Lot Number: 12HM04859
• 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