MAUDE Adverse Event Report: ARTHREX, INC. UKA TIBIAL BEARING, SIZE 3, 8MM, VIT-E; KNEE PROSTHESIS

Model Number	UKA TIBIAL BEARING, SIZE 3, 8MM, VIT-E
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, prying/leveraging the device and/or excessive force being used during insertion of the implant.
Event or Problem Description
On 3/23/2023, it was reported by a sales representative via email that an ar-521-tbc8 ibalance uka tibial bearing implant would not insert or engage in the tibial tray.No further information was provided.Additional information requested.

• Brand Name: UKA TIBIAL BEARING, SIZE 3, 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: 19483905
• Report Number: 1220246-2024-05198
• Device Sequence Number: 7905990
• Product Code: HSX
• UDI-Device Identifier: 00888867233195
• UDI-Public: 00888867233195
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 06/07/2024

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: 10/31/2024
• Device Model Number: UKA TIBIAL BEARING, SIZE 3, 8MM, VIT-E
• Device Catalogue Number: AR-521-TBC8
• Device Lot Number: 5791943
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2019
• 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