MAUDE Adverse Event Report: ARTHREX, INC. PS TIBIAL BEARING, SIZE 5, 8MM, VIT E; KNEE PROSTHESIS PAT/FEM/TIB

Model Number	PS TIBIAL BEARING, SIZE 5, 8MM, VIT E
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
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 10/23/2024, it was reported by a arthrex employee via phone that an ar-523-b508 tibial bearing would not seat in the tibial tray.This occurred during use in a case with no patient effect.Case completed using another tibial implant.No delay to case.
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 due to misaligned insertion and/or improper bone preparation.

• Brand Name: PS TIBIAL BEARING, SIZE 5, 8MM, 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: 20685476
• Report Number: 1220246-2024-08529
• Device Sequence Number: 20693270
• Product Code: MBH
• UDI-Device Identifier: 00888867232556
• UDI-Public: (01)00888867232556(11)201101(17)251031(10)579203867
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: 10/31/2025
• Device Model Number: PS TIBIAL BEARING, SIZE 5, 8MM, VIT E
• Device Catalogue Number: AR-523-B508
• Device Lot Number: 579203867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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