MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	74022117
Health Effect - Clinical Code	Joint Swelling (2356)
Date of Event	02/01/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This foreign event has not resulted in manufacturer¿s indication to the regulatory agency of the country in which the incident occurred the intention to take corrective actions for a device which is available for sale in canada.Therefore it must not be reported to health (b)(6) in accordance with the medical device regulations.
Event or Problem Description
It was reported to us through retrospective clinical trial that patient underwent other conservative approach in order to solve right knee swelling.Outcome of this event is resolved on (b)(6) 2013 and severity was deemed as mild.
Additional Manufacturer Narrative
Based on additional information received from the study site, which contained clarification to previously reported data, this event was re-determined and it was concluded that the reported complaint does not represent an event which requires reporting per cfr 21 part 803.For this reason we ask you to disregard report 1020279-2017-00496.

• Brand Name: JRNY BCS II FEMORAL OXIN RT SZ 7
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6688843
• Report Number: 1020279-2017-00496
• Device Sequence Number: 18846508
• Product Code: JWH
• UDI-Device Identifier: 00885556170014
• UDI-Public: 00885556170014
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2017

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 Model Number: 74022117
• Device Catalogue Number: 74022117
• Device Lot Number: 12FM11238
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/16/2017; 07/16/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 07/17/2017; 08/08/2017
• 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 6, 74022216/UNK LOT; JRNY BCS PAT RESRF RD 38 MM STD, 74024838/UNK LOT; JRNY II BCS XLPE ARTISRT (B)(4) 74027252/UNK
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 96