MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; MOTO MEDIAL TIBIAL TRAY S3 LM

Model Number	02.18.TF3.LM
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to tibial tray subsidence at 2 weeks from primary.Gmk-sphere successfully implanted.
Additional Manufacturer Narrative
Batch review performed on 23 dec 2025.Lot 2419729: (b)(4) items manufactured and released on 30-sept-2024.Expiration date: 2029-sept-16.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by clinical affair manager.A revision surgery was performed approximately two weeks after implantation of a medial partial knee arthroplasty due to collapse of the tibial hemiplateau.The available x-ray images clearly demonstrate collapse of the bone, followed by displacement of the tibial tray.Based on the information currently available, the root cause cannot be conclusively determined.However, reduced bone strength potentially associated with routine surgical bone preparation may have contributed to the occurrence of this early fracture.There is no evidence to suggest a device malfunction or defect.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: MOTO MEDIAL TIBIAL TRAY S3 LM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 24004368
• Report Number: 3005180920-2026-00015
• Device Sequence Number: 13308043
• Product Code: HSX
• UDI-Device Identifier: 07630030896736
• UDI-Public: 07630030896736
• Combination Product (Y/N): N
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: 02.18.TF3.LM
• Device Lot Number: 2419729
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2024
• 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: Required Intervention
• Patient Sex: Female