MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; MOTO PARTIAL KNEE 02.18.IF2.08.LM TIBIAL INSERT FIX S2 LM - 8MM

Model Number	02.18.IF2.08.LM
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 13 jun 2025.Lot: 2407829: (b)(4) items manufactured and released on 28-may-2024.Expiration date: 2029-05-14.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.Other device involved: moto partial knee 02.18.Tf2.Lm tibial tray fix cemented s2 lm (k162084), lot: 2430922: (b)(4) items manufactured and released on 10-feb-2025.Expiration date: 2030-01-26.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.Conclusions not yet available.
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 instead.Surgery completed with 20 min delay.
Additional Manufacturer Narrative
Device not available.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 02.18.IF2.08.LM TIBIAL INSERT FIX S2 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: 22467161
• Report Number: 3005180920-2025-00644
• Device Sequence Number: 17168012
• Product Code: HSX
• UDI-Device Identifier: 07630030895852
• UDI-Public: 07630030895852
• 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
• 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): 10/02/2025

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.IF2.08.LM
• Device Lot Number: 2407829
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2024
• 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: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White