MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY II UK TIB INSRT MED SZ 7-8 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	74026718
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference:(b)(4).
Event or Problem Description
It was reported that, after a tka had been performed on (b)(6) 2023, the patient underwent an i+d and on (b)(6) 2023 revision surgery was performed to replace one (1) journey ii uk med tib base sz 8 lt.Patient's current health status is unknow.
Additional Manufacturer Narrative
B2: outcomes attributed to adverse event b1: adverse event and/or product problem , b5: describe event or problem, d1: brand name, d4: catalog#, lot#, expiration date and unique identifier (udi) # and h4: device manufacture date.
Event or Problem Description
It was reported that, after a uka had been performed on (b)(6) 2023, the patient underwent an i+d on (b)(6) 2023.The jrny ii uni med xlpe insert sz 7-8 8mm was removed and replaced.Patient's current health status is unknown.
Additional Manufacturer Narrative
Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals scratches and gouges in the surface of the device.A dimensional evaluation could not confirm or explain the stated failure mode.The damage/deformation of several features would not allow for accurate measurement.All measurable critical features that could be measured were within specification.The dimensional inspection of the returned device did not indicate the product was defective at the time of shipment from the manufacturing site.This device is subjected to multiple visual and dimensional inspection during processing, and this type of damage has a high likelihood of detection during these inspections.Based on the evidence provided, the unsatisfactory experience could be confirmed.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that per complaint details, within five months of a tka, the patient had an i+d as well as a revision surgery in which the poly insert was exchanged.As of the date of this medical investigation, the requested clinical documentation has not been provided for evaluation.Therefore, there were no clinical factors found which would have contributed to the reported revision.The patient impact beyond that which has already been reported not be determined with the limited information.No further clinical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management and information for use files revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of the instructions for use document for unicompartmental knee system provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.No details about the cause of the revision surgery were provided, therefore no factors that can contribute can be delineated.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURNEY II UK TIB INSRT MED SZ 7-8 8MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17358397
• Report Number: 1020279-2023-01474
• Device Sequence Number: 6893494
• Product Code: HSX
• UDI-Device Identifier: 00885556677209
• UDI-Public: 00885556677209
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K190085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 74026718
• Device Catalogue Number: 74026178
• Device Lot Number: 21MAP0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 08/07/2023; 08/18/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/07/2023; 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown