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

Model Number	02.18.003LM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At 1 year 8 months from the primary, the patient came in due to stiffness and lack of full extension of the knee.The cause is unknown.The surgeon revised the knee from a moto system to spherika.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 07 nov 2025.Moto partial knee 02.18.003lm moto medial femoral component s3 lm (k162084) lot 2317034: (b)(4) items manufactured and released on 29-aug-2023.Expiration date: 2028-aug-15.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.Moto partial knee 02.18.If3.08.Lm moto medial tibial insert s3 lm - h8 (k162084) lot 2304564: (b)(4) items manufactured and released on 10-jul-2023.Expiration date: 2028-jun-21.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.Moto partial knee 02.18.Tf3.Lm moto medial tibial tray s3 lm (k162084) lot 2315388: (b)(4) items manufactured and released on 27-sept-2023.Expiration date: 2028-sept-09.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.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: MOTO MEDIAL FEMORAL COMPONENT 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: 23615349
• Report Number: 3005180920-2025-01138
• Device Sequence Number: 21095226
• Product Code: HSX
• UDI-Device Identifier: 07630030895579
• UDI-Public: 07630030895579
• Combination Product (Y/N): N
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/21/2025

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: 02.18.003LM
• Device Lot Number: 2317034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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: 79 YR
• Patient Sex: Female