MAUDE Adverse Event Report: ARTHREX, INC. UKA TIBIAL BEARING, SIZE 1, 8MM, VIT-E; KNEE PROSTHESIS

Model Number	UKA TIBIAL BEARING, SIZE 1, 8MM, VIT-E
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On (b)(6) 2025, it was reported by a sales representative via email that two ar-521-tba8 ibalance uka tibial bearing implants failed to snap into the tray.Multiple techniques were attempted, and the tray was confirmed to be free of debris; however, neither 8mm tibial bearings could be secured into the locking tabs.The component remained proud either at the central portion or on the medial side of the tray.This issue was identified during a right medial uka procedure on (b)(6) 2025.Additional information requested on 6/25/2025.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to use error.The surgical technique guide, lt1-00017-en_f, outlines the following under tibial component: insert the tibial bearing implant after the cement has fully cured.Remove the tibial bearing trial using the tibial bearing trial puller instrument.Insert the final tibial bearing component into the tibial tray component anteriorly with the articulating surface facing the femoral component.Slide the tibial bearing component posteriorly until the posterior slot on the bearing engages the posterior lip on the tibial tray.Push the anterior edge of the tibial bearing down into the tibial tray component using thumb pressure until it snaps into place.Note: there is a 5° clearance built into the tibial bearing to allow for ease of insertion.It is normal for there to be a small gap at the anterior aspect in between the tibial bearing and the tibial tray once the bearing is fully seated.

• Brand Name: UKA TIBIAL BEARING, SIZE 1, 8MM, VIT-E
• Common Device Name: KNEE PROSTHESIS
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22469173
• Report Number: 1220246-2025-02831
• Device Sequence Number: 4234511
• Product Code: HSX
• UDI-Device Identifier: 00888867231283
• UDI-Public: (01)00888867231283(11)231001(17)280930(10)579232815
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K161060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UKA TIBIAL BEARING, SIZE 1, 8MM, VIT-E
• Device Catalogue Number: AR-521-TBA8
• Device Lot Number: 579232815
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown