MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURN ART INS BCS STD 5-6 LT 9; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74023261
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to pain and instability.At first it was thought that the peg was broken but when opening the knee and performing further inspection, surgeon determined that patient had developed osteoporosis and the femoral bone collapsed as a result.This caused the pain and instability.Prosthesis was removed and a legion revision was on hand to complete in 1 stage.
Additional Manufacturer Narrative
It was reported a revision surgery was performed due to pain and instability.When opening the knee and performing further inspection, surgeon determined that patient had developed osteoporosis and the femoral bone collapsed as a result.The associated journey tibial base plate, journey oxinium femoral component and journey articular insert, used in treatment, 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 could not be corroborated.Review of the instructions for use and risk management files identified the reported failure as potential adverse events.A medical analysis noted that two x-ray pictures and one intraoperative picture were received which demonstrate that there is a posterior positioning of the femoral component but it is not known if this is the original location or rotation over time due to the reported femoral bone collapse but the later is likely based on the complaint report.As stated, the root cause was determined as patient osteoporosis and collapse of femoral bone.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew 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: JOURN ART INS BCS STD 5-6 LT 9
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9187417
• Report Number: 1020279-2019-03652
• Device Sequence Number: 14059670
• Product Code: JWH
• UDI-Device Identifier: 03596010555205
• UDI-Public: 03596010555205
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: 04/02/2018
• Device Model Number: 74023261
• Device Catalogue Number: 74023261
• Device Lot Number: 08DM04829
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 03/04/2020
• 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