MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 9MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74027261
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed.Insert was explanted as it presented a diffuse pitting on the surface.
Event or Problem Description
It was reported that a revision surgery was performed.During an arthroscopic knee surgery due to pain it was noticed that the insert presented a diffuse pitting on the surface.It was explanted.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to pain.The associated journey ii bcs articular insert, used in treatment, was returned and evaluated.The patellar component was not returned.A lab analysis conducted during this investigation noted that the examination showed signs of wear, deformation, and discoloration of the tibial insert.The explantation of the insert likely caused some of the deformation observed during this investigation.The discoloration is likely due to the absorption of biological fluids.Our investigation including a review of the manufacturing records for the listed batch of the insert did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part 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 product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident or adverse event could not be corroborated.No information was provided for the patellar component.A review of instructions for use revealed the alleged failure is previously identified in the possible adverse events.Per our risk assessment, probable causes could include but not limited to abnormal motion over time.Based on this investigation, the need for corrective action is not indicated.No further investigation warranted for this complaint; however we 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 5-6 LT 9MM
• 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: 9168989
• Report Number: 1020279-2019-03594
• Device Sequence Number: 3885127
• Product Code: JWH
• UDI-Device Identifier: 00885556177969
• UDI-Public: 00885556177969
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2020

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: 02/01/2026
• Device Model Number: 74027261
• Device Catalogue Number: 74027261
• Device Lot Number: 16BM03298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/12/2019; 01/30/2020
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 10/14/2019; 02/05/2020
• 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