MAUDE Adverse Event Report: ARTHREX, INC. UKA TIBIAL BEARING, SIZE 2, 9MM, VIT-E; KNEE PROSTHESIS

Model Number	UKA TIBIAL BEARING, SIZE 2, 9MM, VIT-E
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2024
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) 2024, it was reported by a sales representative via email that an ar-521-tbb9 tibial bearing implant would not lock into the tibial tray the tibial bearing implant was removed, and it was determined that the locking mechanism on the bearing was damaged.This was discovered during a uka procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information received on 2/21/2025: the sales representative provided the part number ar-511-t2r ibalance uka tibial tray cemented size 2 right medial left lateral.The ar-521-tbb9 tibial bearing implant was removed, and a new one was used with the same tibial tray.Nothing broke in the patient, and the case was not delayed; additional anesthesia was not necessary.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint allegation is confirmed.Upon visual inspection, it was noted that the uka tibial bearing, size 2, 9mm, vit-e was cracked/broken, and the edges were damaged.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion and/or excessive force being used during insertion of the implant.Functional testing was not performed due to the damage to the device.

• Brand Name: UKA TIBIAL BEARING, SIZE 2, 9MM, 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: 21167928
• Report Number: 1220246-2025-09483
• Device Sequence Number: 21218792
• Product Code: HSX
• UDI-Device Identifier: 00888867231375
• UDI-Public: (01)00888867231375(11)201201(17)251130(10)579202671
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2025

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 Expiration Date: 11/30/2025
• Device Model Number: UKA TIBIAL BEARING, SIZE 2, 9MM, VIT-E
• Device Catalogue Number: AR-521-TBB9
• Device Lot Number: 579202671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: Not provided; 06/03/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/07/2025; 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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
• Patient Sex: Unknown