MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; MOTO MEDIAL TIBIAL TRAY S1 LM

Model Number	02.18.TF1.LM
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs manager: a revision surgery was performed approximately one year after primary implantation of a uka, due to collapse of the medial tibial hemiplateau.The available x-ray images clearly confirm the event, showing displacement of the tibial component, most likely secondary to bone failure.The underlying cause is difficult to determine and is likely multifactorial.Possible contributing factors include patient-specific bone quality, mechanical loading, and potentially incongruous movements.Based on the information provided, there is no evidence to suggest a device malfunction or manufacturing defect.Batch review performed on 11 february 2026: lot 2338953: (b)(4) items manufactured and released on 12-feb-2024.Expiration date: 2029-jan-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.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.
Event or Problem Description
Revision surgery at about 1 month post-primary due to tibial tray collapse, happened secondary to a bone collapse.All device revised successfully and gmk-revision implants were used.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: MOTO MEDIAL TIBIAL TRAY S1 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: 24454905
• Report Number: 3005180920-2026-00148
• Device Sequence Number: 9969225
• Product Code: HSX
• UDI-Device Identifier: 07630030896699
• UDI-Public: 07630030896699
• 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: 2026
• 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): 02/26/2026

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.TF1.LM
• Device Lot Number: 2338953
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2024
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White