MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SMI-CONSTRAINED,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	74027271
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/24/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented with right knee genicular neuralgia and right knee pain.The surgeon performed procedures: fluoroscopic guidance for needle replacement, right superomedial genicular branch of the saphenous nerve block, right superolateral genicular branch of the femoral nerve block, right inferomedial genicular branch of the saphenous nerve block, right medial genicular branch from the vastus intermedius nerve block.
Additional Manufacturer Narrative
Please review attached for investigation results.
Additional Manufacturer Narrative
[(b)(4)].
Additional Manufacturer Narrative
Additional information received, identified that this event should be re-evaluated for mdr reporting.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 7-8 RT 9MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SMI-CONSTRAINED,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6907460
• Report Number: 1020279-2017-00811
• Device Sequence Number: 10948957
• Product Code: JWH
• UDI-Device Identifier: 00885556179710
• UDI-Public: 00885556179710
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/23/2018

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 Catalogue Number: 74027271
• Device Lot Number: 13KM11799
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 08/30/2017; 08/30/2017; 08/30/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 02/19/2018; 02/20/2018; 05/23/2018
• 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: Required Intervention
• Patient Age: 74 YR