MAUDE Adverse Event Report: ARTHREX, INC. UKA TIBIAL BEARING, SIZE 5, 8MM, VIT-E; KNEE PROSTHESIS

Model Number	UKA TIBIAL BEARING, SIZE 5, 8MM, VIT-E
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
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.Complaint confirmed.One unpackaged ar-521-tbe8, batch 579202821 was received for investigation.Visual inspection identified chipping and breakage across one end of the implant.Surface damage was present across the engraved part and lot numbers.Due to the returned condition of the device, the dimensions could not be accurately assessed.The most likely cause for the reported failure can be attributed to user error due to excessive force during use.
Event or Problem Description
It was reported during a knee procedure, the ar-521-tbe8 (lot: 579202821)tibial bearing implant would not seat into the tibial tray.The case was completed using a 2nd ar-521-tbe8 (579200004)tibial bearing implant.

• Brand Name: UKA TIBIAL BEARING, SIZE 5, 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: 19444683
• Report Number: 1220246-2024-04663
• Device Sequence Number: 7165171
• Product Code: HSX
• UDI-Device Identifier: 00888867233317
• UDI-Public: 00888867233317
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K161060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/02/2024

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: 10/31/2025
• Device Model Number: UKA TIBIAL BEARING, SIZE 5, 8MM, VIT-E
• Device Catalogue Number: AR-521-TBE8
• Device Lot Number: 579202821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 06/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2020
• 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