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	Positioning Problem (3009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/13/2021
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 not confirmed, the device was returned damaged and deformed and could not be functionally tested or measured.The damage was likely caused by impacting the device, however the surgical technique requires assembly with pressure from the thumb.A new ar-521-tbe8 from the same batch was ordered from inventory with no abnormalities observed.The cause of the event is undetermined.
Event or Problem Description
On 12/13/2021 it was reported by a sales representative via e-mail that an ar-521-tbe8 ibalance uka tibial bearing implant tibial insert failed to seat properly with no soft tissue, bone or cement interfering with the locking mechanism.This was discovered during a uka procedure.The case was completed by using a new ar-521-tbe8.

• 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: 19569571
• Report Number: 1220246-2024-06189
• Device Sequence Number: 6948257
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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: 01/03/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 06/19/2024
• 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