MAUDE Adverse Event Report: ARTHREX, INC. UKA TIBIAL BEARING, SIZE 2, 8MM, VIT-E; KNEE PROSTHESIS

Model Number	UKA TIBIAL BEARING, SIZE 2, 8MM, VIT-E
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by a distributor via sems-07011239 that an ar-521-tbb8 ibalance® uka tibial bearing implants initial insert had to be removed and a larger one placed after changing the tibia.The implant was verified and the reported damage was confirmed.This occurred during use.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 user error of the device due to applying excessive mechanical forces upon insertion.

• Brand Name: UKA TIBIAL BEARING, SIZE 2, 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: 22962088
• Report Number: 1220246-2025-03725
• Device Sequence Number: 9515072
• Product Code: HSX
• UDI-Device Identifier: 00888867231368
• UDI-Public: (01)00888867231368(11)231001(17)280930(10)579232811
• Combination Product (Y/N): N
• PMA/510(K) Number: K161060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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 2, 8MM, VIT-E
• Device Catalogue Number: AR-521-TBB8
• Device Lot Number: 579232811
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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