MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; TIBIAL INSERT FIX S4 RM - 8MM

Model Number	02.18.IF4.08.RM
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Tibial insert 8mm could not be coupled with the tibial tray; 9mm insert was used and the surgery was completed successfully.No tibia recut needed.The surgery was prolonged by about 20 minutes.Devices coupled in backtable.
Additional Manufacturer Narrative
Batch review performed on 28 july 2025.Lot 2426815: (b)(4) items manufactured and released on 09/11/2024.Expiration date: 23/10/2029.No anomalies found related to the problem.To date, 27 items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: TIBIAL INSERT FIX S4 RM - 8MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22781806
• Report Number: 3005180920-2025-00823
• Device Sequence Number: 8127700
• Product Code: HSX
• UDI-Device Identifier: 07630030896101
• UDI-Public: 07630030896101
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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 Model Number: 02.18.IF4.08.RM
• Device Lot Number: 2426815
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2024
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Hispanic
• Patient Race: White