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 Codes	Positioning Failure (1158); Fitting Problem (2183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2024
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 06/11/2024, it was reported by a sales representative via phone that an ar-521-tbb8 ibalance® uka tibial bearing implant was not locking into the tibial tray.This occurred during a partial knee replacement on (b)(6) 2024 that was completed using another ar-521-tbb8 ibalance® uka tibial bearing implant.
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.

• 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: 19683702
• Report Number: 1220246-2024-06605
• Device Sequence Number: 3115508
• Product Code: HSX
• UDI-Device Identifier: 00888867231368
• UDI-Public: 00888867231368
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 09/30/2025
• Device Model Number: UKA TIBIAL BEARING, SIZE 2, 8MM, VIT-E
• Device Catalogue Number: AR-521-TBB8
• Device Lot Number: 579202549
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown