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

Catalog Number	74022118
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Swelling (2356)
Date of Event	10/11/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a knee aspiration was performed due to swelling of right knee.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.A review of complaint history for listed parts revealed no prior complaints for this failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.Based on the available information, the root cause of this patient¿s knee swelling cannot be concluded.However, this patient¿s gout cannot be excluded, as a contributing factor in this event.No further information on the patient¿s status has been provided.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: JRNY BCS II FEMORAL OXIN RT SZ 8
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7302364
• Report Number: 1020279-2018-00247
• Device Sequence Number: 11236095
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2018

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: 05/01/2022
• Device Catalogue Number: 74022118
• Device Lot Number: 12EM02389
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 02/05/2018; 02/05/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 04/02/2018; 04/17/2018
• 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: Other; Required Intervention
• Patient Age: 64 YR