MAUDE Adverse Event Report: ARTHREX, INC. IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5; KNEE PROSTHESIS PAT/FEM/TIB

Model Number	IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/23/2021 it was reported by a sales representative via sems that an ar-513-t5 tibial bearing poly was found to be somewhat loose upon implantation to tibial tray.This was discovered during a case, with no patient effect reported.
Additional Manufacturer Narrative
Per (b)(4) rev.24.0, product history reviews are required for all complaints classified as an early warning or adverse event and any complaint where investigation reveals a confirmed cause category of design, process, product, or supplier.The most likely cause for the reported failure can be attributed to improper bone prep and/or misaligned insertion.

• Brand Name: IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5
• 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: 19277004
• Report Number: 1220246-2024-02998
• Device Sequence Number: 7659841
• Product Code: MBH
• UDI-Device Identifier: 00888867187887
• UDI-Public: 00888867187887
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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: 02/28/2026
• Device Model Number: IBALANCE TKA, MODULAR TIBIAL TRAY, SZ 5
• Device Catalogue Number: AR-513-T5
• Device Lot Number: 12930641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2021
• 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
• Patient Sex: Unknown