MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PFJ SYSTEM; MOTO PATELLA E-CROSS Ø32

Model Number	02.15.E032
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 25 nov 2025.Moto partial knee 02.15.E032 moto patella e-cross d 32 lot.2504638: (b)(4) items manufactured and released on 30 april 2025.Expiration date: 15 april 2030.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 was performed 2 months after the primary surgery due to patella dislocation.The surgeon carried out a manual lateral release and secured the patella with sutures.Only the liner was revised during the procedure.The surgery was completed successfully.

• Brand Name: MOTO PFJ SYSTEM
• Common Device Name: MOTO PATELLA E-CROSS Ø32
• 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: 23669509
• Report Number: 3005180920-2025-01204
• Device Sequence Number: 21257609
• Product Code: HSX
• UDI-Device Identifier: 07630971262539
• UDI-Public: 07630971262539
• Combination Product (Y/N): N
• PMA/510(K) Number: K213071
• 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): 11/28/2025

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: 02.15.E032
• Device Lot Number: 2504638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2025
• 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: Other
• Patient Sex: Unknown