MAUDE Adverse Event Report: ARTHREX, INC. UKA TIBIAL BEARING, SIZE 4, 10MM, VIT-E; KNEE PROSTHESIS

Model Number	UKA TIBIAL BEARING, SIZE 4, 10MM, VIT-E
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
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, a sales representative reported via email that an ar-521-tbd0 ibalance uka tibial bearing implant malfunctioned during insertion and failed to lock into the tibial tray.This was discovered during a uka procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 06/27/2025: during the procedure, the ar-521-tbd0 ibalance uka tibial bearing implant partially engaged.Mild resistance was encountered during insertion.During the attempted insertion, the locking tabs of the implant broke.All fragments were retrieved from the patient.To complete the case, a second ar-521-tbd0 was opened and successfully used.The surgery was not delayed, and no additional anesthesia was required.There have been no reports of patient harm or adverse effects on or after the procedure.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-521-tbd0, ibalance® uka tibial bearing implant, vit e, size 4, 10 mm thickness, batch 579230415, was returned for evaluation.Visual evaluation revealed indentations in the structural body of the tibial bearing, along the edges of the device.The most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces during insertion/extraction of the trial.The complaint allegation is confirmed.

• Brand Name: UKA TIBIAL BEARING, SIZE 4, 10MM, 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: 22507727
• Report Number: 1220246-2025-02870
• Device Sequence Number: 8788417
• Product Code: HSX
• UDI-Device Identifier: 00888867233218
• UDI-Public: (01)00888867233218(11)230301(17)280229(10)579230415
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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 4, 10MM, VIT-E
• Device Catalogue Number: AR-521-TBD0
• Device Lot Number: 579230415
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown