MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	74022124
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094)
Date of Event	09/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient presented with abnormality of gait; synovitis and tenosynovitis; left knee pain during the month/years following, left tka.The patient underwent an aspiration of the left knee.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Please see attached file for our results of investigation.(b)(4).
Additional Manufacturer Narrative
A reassessment of the event reported through this report concluded that multiple previously reported events represent a single occurence of an event.For this reason we consider that event reported through this report represents a duplicate of the event reported through mdr 1020279-2017-00634.

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6802291
• Report Number: 1020279-2017-00639
• Device Sequence Number: 1236497
• Product Code: JWH
• UDI-Device Identifier: 00885556170366
• UDI-Public: 00885556170366
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/01/2018

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: 04/08/2023
• Device Catalogue Number: 74022124
• Device Lot Number: 13DM07889
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 08/09/2017; 08/09/2017; 08/09/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 10/05/2017; 10/13/2017; 06/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR