MAUDE Adverse Event Report: ARTHREX, INC. PS TIBIAL BEARING, SIZE 5, 11MM, VIT E; KNEE PROSTHESIS PAT/FEM/TIB

Model Number	PS TIBIAL BEARING, SIZE 5, 11MM, VIT E
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a procedure the ar-523-b511, tibial bearing, made a weird clicking sound.The surgeon did not feel comfortable with the fixation and choose to remove the implant.A similar implant was opened and used to complete the case without any adverse effects.Additional information 6/7/2021 it was reported during a total knee replacement procedure the ar-523-b511, tibial bearing, made a weird clicking sound.The surgeon did not feel comfortable with the fixation and choose to remove the implant.A similar implant was opened and used to complete the case without any adverse effects.
Additional Manufacturer Narrative
Complaint not confirmed.The device locking mechanism was slightly deformed due to the attempted assembly with the tray.The device was however assembled with a tray sample and was found to be properly secured with no clocking other than when the locking mechanism engaged.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.

• Brand Name: PS TIBIAL BEARING, SIZE 5, 11MM, VIT E
• Common Device Name: KNEE PROSTHESIS PAT/FEM/TIB
• 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: 18876599
• Report Number: 1220246-2024-01407
• Device Sequence Number: 7876357
• Product Code: MBH
• UDI-Device Identifier: 00888867232587
• UDI-Public: 00888867232587
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K171365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/11/2024

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: 06/30/2024
• Device Model Number: PS TIBIAL BEARING, SIZE 5, 11MM, VIT E
• Device Catalogue Number: AR-523-B511
• Device Lot Number: 5791923
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• 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