MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM; MOTO MEDIAL E-CROSS TIBIAL INSERT S3 LM - H8

Model Number	02.18.EIF3.08.LM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2026: moto partial knee 02.18.Eif3.08.Lm moto medial e-cross tibial insert s3 lm - h8 (k213071) lot 2415678: (b)(4) items manufactured and released on 08-aug-2024.Expiration date: 28-jul-2029.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.Lm moto medial tibial tray s3 (k162084) lot 189262: (b)(4) items manufactured and released on 13-mar-2019.Expiration date: 03-mar-2024.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Moto partial knee 02.18.003lm moto medial femoral component s3 lm (k162084) lot 2116402: (b)(4) items manufactured and released on 09-feb-2022.Expiration date: 26-jan-2027.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.Root cause: the developmental instability is a rather commonly described possible complication following uka, because soft tissue may stretch and provide insufficient stability.It is therefore common practice to resort to a thicker insert and recreate soft tissue tension.
Event or Problem Description
The patient had primary uka left knee surgery on (b)(6) 2022.On (b)(6) 2025, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the liner.The surgery was completed successfully [mdr 2025-00360].On (b)(6) 2026, the patient had instability and the cause is unknown.There was no reports of trauma.The surgeon revised the knee to a total knee arthroplasty.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE SYSTEM
• Common Device Name: MOTO MEDIAL E-CROSS TIBIAL INSERT S3 LM - H8
• 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: 25442519
• Report Number: 3005180920-2026-00537
• Device Sequence Number: 5740567
• Product Code: HSX
• UDI-Device Identifier: 07630345711472
• UDI-Public: 07630345711472
• 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: 2026
• 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): 06/09/2026

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.EIF3.08.LM
• Device Lot Number: 2415678
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2024
• 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: Required Intervention
• Patient Sex: Female
• Patient Race: White