MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; MOTO MEDIAL TIBIAL INSERT S4 LM - H9

Model Number	02.18.IF4.09.LM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 31 october 2025: moto partial knee 02.18.If4.09.Lm moto medial tibial insert s4 lm - h9 (k162084) lot 2349453: (b)(4)items manufactured and released on 11-apr-2024.Expiration date: 2029-03-26.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.Tf4.Lm moto medial tibial tray s4 lm (k162084) moto partial knee 02.18.If4.09.Lm moto medial tibial insert s4 lm - h9 (k162084) lot 2409978: (b)(4) items manufactured and released on 05-jun-2024.Expiration date: 2029-05-16.No anomalies found related to the problem.To date, 8 items of the same lot have been sold with no similar reported event during the period of review.Moto partial knee 02.18.Tf4.Lm moto medial tibial tray s4 lm (k162084) lot.2415665: (b)(6) items manufactured and released on 07-aug-2024.Expiration date: 2029-07-23.No anomalies found related to the problem.To date, 20 items of the same lot have been sold with no similar reported event during the period of review.Visual inspection performed by medacta r&d knee project manager: during a uni knee arthroplasty procedure, the surgeon was unable to properly engage the first tibial insert with the tibial tray.A second insert was subsequently attempted, with the same result.A third insert of a different thickness (8 mm) was successfully engaged and implanted without issue.The use of the 8 mm liner was deemed clinically appropriate.A visual inspection was performed on the two tibial inserts that could not be engaged.The posterior region of both inserts' locking mechanisms exhibited visible mechanical damage, including bending and plastic deformation.No other abnormalities were noted on the articulating surface or peripheral geometry of the components.Based on the observed deformation, it is presumed that during the initial attempt to couple the insert with the tibial baseplate, the insert may not have been properly aligned or fully seated within the tray.The subsequent application of force under misalignment likely caused permanent damage to the posterior locking feature, preventing proper engagement on further attempts.A review of the production and quality records for the affected lots identified no manufacturing nonconformities.Other inserts from the same production lots have been implanted without reported issues or related complaints.Based on the results of the visual inspection and available information, there is no evidence indicating a manufacturing defect or device malfunction.Root cause: although no root cause can be confirmed for this case, it is most likely that in the first attempts to fix the insert into the baseplate, the insert was not well positioned and became damaged, precluding the possibility to fix the insert in the following attempts.The investigation does not indicate a potential manufacturing related issue or systemic deficiency.
Event or Problem Description
The surgeon attempted to insert the liner into the tibial tray, but it didn't lock securely.A second insert was used; however, it also failed to lock properly.The cause of these issues remains unknown.Finally, an 8mm insert was successfully fixed, and the surgery was completed without further complications.The total surgery time was 2 hours, including a 40-minute delay.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: MOTO MEDIAL TIBIAL INSERT S4 LM - H9
• 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: 23437070
• Report Number: 3005180920-2025-01051
• Device Sequence Number: 4732952
• Product Code: HSX
• UDI-Device Identifier: 07630030896118
• UDI-Public: 07630030896118
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.18.IF4.09.LM
• Device Lot Number: 2349453
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian