MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR INS XLPE LAT 3-4 RT 11MM; PROSTHESISKNEPATELLOFEMOROTIBIALSEMICONSTRAINEDCMNTDPOLYMERMETALPOLYMER

Model Number	74023833
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to pain and stiffness.A ball of scar tissue was found and removed.The affected journey ii inserts, used in treatment, were returned.A lab analysis conducted during this investigation noted that examination showed signs of wear, deformation, and discoloration of the tibial insert.The wear found on the articulating surfaces of the tibial inserts are likely due to contact with the femoral component.The deformation found on the insert could have likely been caused by the explantation of the insert.The discoloration is likely due to the absorption of biological fluids.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 adverse event could not be corroborated.Our clinical analysis noted that per office records, this patient has a history of struggled with range of motion.According to the revision report, all components were well fixed.The surgeon removed ¿a large ball¿ of scar tissue located of the right knee and the insert was changed to a smaller size.We cannot rule out, as probable causes, the buildup of scar tissue and the patient¿s history of struggling with range of motion as contributing factors to the reported pain and stiffness as well as the surgeon¿s decision to replace the insert with a smaller size.Based on the change, the selection of the original insert thickness could have been a factor as well.No further investigation warranted for this complaint.Based on this investigation, the need for corrective action is not indicated.
Event or Problem Description
It was reported that a revision surgery was performed due to pain and stiffness.A ball of scar tissue was found and removed.Insert removed.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to pain and stiffness.A ball of scar tissue was found and removed.The affected journey ii inserts, used in treatment, were returned.A lab analysis conducted during this investigation noted that examination showed signs of wear, deformation, and discoloration of the tibial insert.The wear found on the articulating surfaces of the tibial inserts are likely due to contact with the femoral component.The deformation found on the insert could have likely been caused by the explantation of the insert.The discoloration is likely due to the absorption of biological fluids.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 adverse event could not be corroborated.Our clinical analysis noted that per office records, this patient has a history of struggled with range of motion.According to the revision report, all components were well fixed.The surgeon removed ¿a large ball¿ of scar tissue located of the right knee and the insert was changed to a smaller size.We cannot rule out, as probable causes, the buildup of scar tissue and the patient¿s history of struggling with range of motion as contributing factors to the reported pain and stiffness as well as the surgeon¿s decision to replace the insert with a smaller size.Based on the change, the selection of the original insert thickness could have been a factor as well.No further investigation warranted for this complaint.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: JRNY II XR INS XLPE LAT 3-4 RT 11MM
• Common Device Name: PROSTHESISKNEPATELLOFEMOROTIBIALSEMICONSTRAINEDCMNTDPOLYMERMETALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9742013
• Report Number: 1020279-2020-00682
• Device Sequence Number: 19378079
• Product Code: JWH
• UDI-Device Identifier: 00885556615638
• UDI-Public: 00885556615638
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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: 06/14/2026
• Device Model Number: 74023833
• Device Catalogue Number: 74023833
• Device Lot Number: 16FM13173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/02/2020
• 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