MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM - MEDIAL; MOTO MEDIAL FEMORAL COMPONENT S3 RM

Model Number	02.18.003RM
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 april 2026 moto partial knee 02.18.003rm moto medial femoral component s3 rm (k162084) lot.2407825 (b)(4) items manufactured and released on 17-may-2024.Expiration date: 02-may-2029.No anomalies found related to the problem.To date, 35 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 s3 rm (k162084) lot.2422900 (b)(4) items manufactured and released on 24-oct-2024.Expiration date: 09-oct-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.Eif3.08.Rm moto e-cross tibial insert s3 h8 rm (k213071) lot.2426262.(b)(4) items manufactured and released on 06-nov-2024.Expiration date: 22-oct-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.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
Revision surgery performed due to infection, 9 months after the previous revision due to infection (mdr 2025-00628).The surgeon removed the femoral component, insert, and tibial tray, and implanted antibiotic spacers in the knee.The surgery was completed successfully.

• Brand Name: MOTO PARTIAL KNEE SYSTEM - MEDIAL
• Common Device Name: MOTO MEDIAL FEMORAL COMPONENT S3 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: 24871678
• Report Number: 3005180920-2026-00309
• Device Sequence Number: 10020107
• Product Code: HSX
• UDI-Device Identifier: 07630030895586
• UDI-Public: 07630030895586
• Combination Product (Y/N): N
• PMA/510(K) Number: K162084
• 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): 04/14/2026

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: 02.18.003RM
• Device Lot Number: 2407825
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2024
• 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 Age: 41 YR
• Patient Sex: Female
• Patient Weight: 23 KG
• Patient Race: White