MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4 LT 13MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER

Catalog Number	74027245
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/16/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a total knee replacement on (b)(6) 2014.On (b)(6) 2016 a revision surgery was performed due to unspecified reasons.
Additional Manufacturer Narrative
It was reported that patient had a revision surgery due to unspecificied reasons.The affected journey ii bcs femoral component, journey bcs resurfacing patellar component, journey ii bcs articular insert and journey tibial baseplate were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no patient medical records available and no specific reason for revision provided, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: JRNY II BCS XLPE ART ISRT SZ 3-4 LT 13MM
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED,CEMENTED,POLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8108059
• Report Number: 1020279-2018-02619
• Device Sequence Number: 19360851
• Product Code: JWH
• UDI-Device Identifier: 00885556177815
• UDI-Public: 00885556177815
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

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 Expiration Date: 03/24/2023
• Device Catalogue Number: 74027245
• Device Lot Number: 13CM15862
• Initial Date Received by Manufacturer: 11/11/2018
• Supplement Date Received by Manufacturer: 11/11/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 12/06/2019
• 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: 74022124/14FM00013; 74022223/13KM01554; 74024829/13HM11503; 74022124/14FM00013; 74022223/13KM01554; 74024829/13HM11503
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR