MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; MOTO MEDIAL TIBIAL TRAY S2 LM

Model Number	02.18.TF2.LM
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Aseptic loosening (4883)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 january 2026 lot 2013288: (b)(4) items manufactured and released on 18-march-2021.Expiration date: 2026-03-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Lot 2013288a: (b)(4) item manufactured and released on 21-feb-2025.Expiration date: 2030-02-10.No anomalies found related to the problem.Clinical evaluation a revision surgery was performed approximately two months after the implantation of a partial knee arthroplasty.The available x-ray images show a collapse of the medial tibial hemiplateau, with subsequent displacement of the tibial tray.These radiographic findings are consistent with an insufficiency fracture of the tibial bone.Such a condition may be multifactorial in origin.Contributing factors may include weakening of the tibial bone related to standard surgical bone preparation, patient-specific bone quality, and mechanical loading during the early rehabilitation phase, including potentially incongruous movements.Based on the available information, no evidence of device malfunction or manufacturing defect has been identified.Root cause:based on the information available, the tibial component collapse was the result of an insufficiency fracture of the medial tibial hemiplateau potentially related to standard surgical bone preparation, and mechanical loading during early rehabilitation.No evidence suggests that any potential issue with the device caused or contributed to the event, and review of the device history does not indicate any manufacturing-related issue.
Event or Problem Description
At about 2 months after the primary, the patient reported pain associated with tibial component loosening.Radiographic evaluation revealed a fracture of the tibial medial compartment.Patient`s bone quality normal.It is likely that the fracture worsened due to the patient walking on the already fractured tibia while managing pain with medication.The surgeon converted the partial knee arthroplasty to a total knee arthroplasty, and the revision surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: MOTO MEDIAL TIBIAL TRAY S2 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: 24343902
• Report Number: 3005180920-2026-00092
• Device Sequence Number: 13239700
• Product Code: HSX
• UDI-Device Identifier: 07630030896712
• UDI-Public: 07630030896712
• 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): 02/16/2026

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.TF2.LM
• Device Lot Number: 2013288A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2025
• 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: 77 YR
• Patient Sex: Female