MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 LM LOT. 2407819

Model Number	02.18.TF2.LM
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27-dec-2024: lot: 2407819: (b)(4) items manufactured and released on 19-jun-2024.Expiration date: 2029-06-03.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 clinical affairs manager: 2 months after primary medial cemented uka, the tibial bone gives way, possibly because of a traumatic event, and exchange is required.No reason to suspect a faulty implant at the origin of this adverse event.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
At about 2 months after primary, revision has been performed due to tibial bone fracture, the cause is unknown.It is not possible to define if the fracture may be due to traumatic event or to the progressive destabilization of bone.Moto components have been revised successfully and the surgeon implanted gmk sphere femur and insert and gmk revision tibia with high wedges and stem.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S2 LM LOT. 2407819
• 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: 21102487
• Report Number: 3005180920-2024-01167
• Device Sequence Number: 8776031
• Product Code: HSX
• UDI-Device Identifier: 07630030896712
• UDI-Public: 07630030896712
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2025

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: 2407819
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White