MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM; MOTO MEDIAL SENSITIN FEMORAL COMPONENT S2 RM

Model Number	02.18.702RM
Medical Device Problem Codes	Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002); Implant subsidence (4078)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 november 2025 moto partial knee 02.18.702rm moto medial sensitin femoral component s2 rm (k213071) lot 2316362: (b)(4) items manufactured and released on 04-oct-2023.Expiration date: 20-sep-2028.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.Rm moto medial tibial tray cemented s3 rm (k162084) lot 2429906: (b)(4) items manufactured and released on 07-apr-2025.Expiration date: 20-mar-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.Clinical evaluation a revision surgery was performed approximately two weeks after the primary implantation of a uka due to tibial baseplate loosening.The available x-ray images clearly demonstrate mobilization of the tibial component, characterized by anterior tilt and subsidence.Additionally, the femoral component appears to be positioned in flexion, with an imperfect fit to the femoral bone.The early failure of the tibial component is likely multifactorial, potentially related to implant positioning and bone quality.In addition, the reported overload may have contributed to the failure.There is no evidence to suggest a device defect.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
At about 2 weeks after the primary, the patientcame in reporting pain due to a loose and subsided baseplate and the cause is unknown.The patient didn & rsquo; t complain any falls but mentioned possibly overdoing activity, feeling well for the first time in years.The surgeon found the baseplate/polyethylene grossly loose and suspected a cement issue, as the initial fit had been excellent.The surgeon revised all components.The surgery was completed successfully.Additional note for clinical internal analyses: the x-ray shows that the femoral component appears to be positioned in flexion, with an imperfect fit to the femoral bone; thereforethe level 2 change the classification from associated component to malpositioning.

• Brand Name: MOTO PARTIAL KNEE SYSTEM
• Common Device Name: MOTO MEDIAL SENSITIN FEMORAL COMPONENT S2 RM
• 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: 23510665
• Report Number: 3005180920-2025-01095
• Device Sequence Number: 10097832
• Product Code: HSX
• UDI-Device Identifier: 07630345705228
• UDI-Public: 07630345705228
• 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): 11/10/2025

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: 02.18.702RM
• Device Lot Number: 2316362
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2023
• 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 Sex: Female