MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4; KNEE PROSTHESIS PAT/FEM/TIB

Model Number	IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a patient-reported via phone that on (b)(6) 2024, underwent revision surgery to have an ar-513-t4 ibalance tka tibial tray removed.The initial surgery occurred on (b)(6) 2022; the patient was unsure.It was then discovered, about two years later, in late or early of (b)(6) 2024, via x-ray, that the plate had fractured.The patient underwent revision surgery on (b)(6) 2024 to have the plate removed.The case was completed using new implants from another manufacturer.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 a patient-specific event.

• Brand Name: IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4
• 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: 21128835
• Report Number: 1220246-2025-09357
• Device Sequence Number: 15372825
• Product Code: MBH
• UDI-Device Identifier: 00888867187870
• UDI-Public: (01)00888867187870(11)211102(17)261031(10)14455997
• 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
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 4
• Device Catalogue Number: AR-513-T4
• Device Lot Number: 14455997
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown