MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 4; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY

Catalog Number	74022124
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348)
Date of Event	12/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery was performed due to an infection.The cause of the infection is unknown.The insert was replaced to a new one.
Additional Manufacturer Narrative
The associated genesis ii biconvex patellar component, journey tibial baseplate, journey ii bcs femoral component and journey ii articular insert were not returned for evaluation.However, device details were provided.Thus, a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history on the listed parts revealed no prior complaints for the listed batch with the same failure mode.Our investigation noted that these devices were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A clinical analysis noted that no clinical documents were provided.Therefore, no thorough clinical assessment of the reported issue can be rendered at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.If the product associated with this event is returned at a future date, the evaluation will be reopened for investigation.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 4
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8244407
• Report Number: 1020279-2019-00147
• Device Sequence Number: 14097061
• Product Code: JWH
• UDI-Device Identifier: 00885556170366
• UDI-Public: 00885556170366
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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 Catalogue Number: 74022124
• Device Lot Number: 18EM16777
• Initial Date Received by Manufacturer: 12/25/2018
• Supplement Date Received by Manufacturer: 12/25/2018
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 05/02/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 66