MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 LM - 8MM

Model Number	02.18.IF3.08.LM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was not possible to couple the pe 8 mm insert with the fix cemented tibial tray.A new 9 mm insert was used, but the same problem occurred.Eventually, the surgeon was able to seat the liner.Delay 20 min, tot surgery 90 min.No recut needed.
Additional Manufacturer Narrative
Batch review performed on 06 jun 2025 (b)(4) items manufactured and released on 13-jan-2023.Expiration date: 2027-12-20.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional devices involved: moto partial knee 02.18.Tf3.Lm tibial tray fix cemented s3 lm (k162084) lot.2429905 batch review performed on 06 jun 2025.(b)(4) items manufactured and released on 27-jan-2025.Expiration date: 2030-01-13.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.
Additional Manufacturer Narrative
Visual inspection performed by r&d department: the posterior region of the insert's locking mechanism appears lightly damaged, exhibiting signs of bending and plastic deformation.The anterior elastic lip presents signs of plastic deformation with a negative shape compatible with the profile of the tibial tray.It is presumed that during the initial attempt to engage the insert with the baseplate, the insert may not have been properly aligned or seated within the tray.As a result, force applied during this attempt likely caused permanent damage to the locking feature, thereby preventing successful engagement in subsequent attempts.Based on the visual inspection, there is no indication that the incident was caused by 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.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 LM - 8MM
• 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: 22381164
• Report Number: 3005180920-2025-00598
• Device Sequence Number: 18282945
• Product Code: HSX
• UDI-Device Identifier: 07630030895975
• UDI-Public: 07630030895975
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K162084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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.IF3.08.LM
• Device Lot Number: 2240520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic