MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 8; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CMNTD,POLYMER/METAL/POLYMR

Catalog Number	74022118
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
The associated complaint device was not returned for evaluation.Please review attached for investigation results.(b)(4).

• Brand Name: JRNY BCS II FEMORAL OXIN RT SZ 8
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CMNTD,POLYMER/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6906919
• Report Number: 1020279-2017-00810
• Device Sequence Number: 745254
• Product Code: JWH
• UDI-Device Identifier: 00885556170069
• UDI-Public: 00885556170069
• 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
• Report Date (Section B): 11/09/2017

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: 03/17/2024
• Device Catalogue Number: 74022118
• Device Lot Number: 14CM13631
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 11/09/2017
• 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