MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; MOTO PARTIAL KNEE 02.18.TF2.LM TIBIAL TRAY FIX CEMENTED S2 LM

Model Number	02.18.TF2.LM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 4 june 2025: lot 2409292: (b)(4) items manufactured and released on 25-jun-2024.Expiration date: 2029-06-11.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 medacta medical affairs director: few days after cemented uka, the tibial component subsides because the tibial bone gives way quite significantly.The surgeons, reportedly, suspect a traumatic event, denied by the patient, and indeed the aspect of the tibia is perfectly compatible with the sequelae of trauma.Our analysis cannot detrmine the real causes of the bone crash, but there is no reason to suspect a defective device.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.
Event or Problem Description
Revision surgery at about 9 days from primary due to a subsided tibial component.The cause of the subsided tibial component is unknown.The surgeon revised all moto components to spherika components.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: MOTO PARTIAL KNEE 02.18.TF2.LM TIBIAL TRAY FIX CEMENTED S2 LM
• 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: 22326809
• Report Number: 3005180920-2025-00568
• Device Sequence Number: 8410931
• Product Code: HSX
• UDI-Device Identifier: 07630030896712
• UDI-Public: 07630030896712
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K162084
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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.TF2.LM
• Device Lot Number: 2409292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG
• Patient Race: Asian