MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN RT SZ 9; PROSTHSIS,KNEE,PATLLOFEMOROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMER/METAL/POLYMER

Catalog Number	74022119
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/06/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an injection was given to the patient due to knee pain.
Additional Manufacturer Narrative
The affected journey ii bcs femoral oxinium, journey ii bcs articular insert, journey tibial baseplate and journey ii bcs patella resurfacing were not returned for evaluation as they remain implanted.The devices were manufactured in 2011, 2012 & 2013.A review of complaint history on the listed parts revealed no prior complaints for this failure mode with the same batch number.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A clinical evaluation noted no supporting clinical/medical documents have been provided.Therefore a thorough investigation cannot be performed.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.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: JRNY BCS II FEMORAL OXIN RT SZ 9
• Common Device Name: PROSTHSIS,KNEE,PATLLOFEMOROTIBIAL,SMI-CONSTRAIND,CMNTD,POLYMER/METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7519296
• Report Number: 1020279-2018-00938
• Device Sequence Number: 16526081
• Product Code: JWH
• UDI-Device Identifier: 00885556170113
• UDI-Public: 00885556170113
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: 04/10/2023
• Device Catalogue Number: 74022119
• Device Lot Number: 13DM09350A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 08/22/2018
• 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: 74022218-13CM00419; 74024841-12JM06401; 74027271-11MM09190
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR