MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; MOTO PARTIAL KNEE 02.18.TF3.RM TIBIAL TRAY FIX CEMENTED S3 RM

Model Number	02.18.TF3.RM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
In the post op x-rays a little fracture was visible where the pin was inserted for cutting guide fixation.At 2 months post primary a tibial bone deformation is visible.It is due to the bone depression at level of the fracture generated by the pin.No more info is available.No revision surgery reported due to this event.
Additional Manufacturer Narrative
Batch review performed on 4 june 2025.Lot 2427713: (b)(4) items manufactured and released on 07-jan-2025.Expiration date: 2029-12-17.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.Clinical evaluation performed by medical affairs director: few weeks after primary uka, a partial tibial subsidence is observed.According to the report, the surgeon believes that a position too lateral of the resection guide fixation pin may have been the cause of this event.We think that this is a typo and they actually meant too medial; in either case, the quality of the image is not sufficient to positively determine this, but it's conceivable that this may have been the cause.The expected evolution, at this stage, is unknown.The crack will likely consolidate spontaneously, but the final joint architecture remains to be seen.We have no reason to suspect a faulty device at the origin of this situation.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 investigation does not indicate any potential manufacturing related issue.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: MOTO PARTIAL KNEE 02.18.TF3.RM TIBIAL TRAY FIX CEMENTED S3 RM
• 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: 22141038
• Report Number: 3005180920-2025-00507
• Device Sequence Number: 7060524
• Product Code: HSX
• UDI-Device Identifier: 07630030896743
• UDI-Public: 07630030896743
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/04/2025

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.TF3.RM
• Device Lot Number: 2427713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White