MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MOTO PARTIAL KNEE SYSTEM; MOTO MEDIAL E-CROSS TIBIAL INSERT S6 LM - H8

Model Number	02.18.EIF6.08.LM
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 may 2026: moto partial knee 02.18.Eif6.08.Lm moto medial e-cross tibial insert s6 lm - h8 (k213071) lot.2314140: (b)(4) items manufactured and released on 11-oct-2023.Expiration date: 2028-sep-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Moto partial knee 02.18.006lm moto medial femoral component s6 lm (k162084) lot.2514319: (b)(4) items manufactured and released on 23-jul-2025.Expiration date: 2030-jul-09.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.Tf6.Lm moto medial tibial tray s6 lm lot.172241b: (b)(4) items manufactured and released on 26-sep-2017.Expiration date: 2022-aug-27.No anomalies found related to the problem.To date, (b)(4) items from the same lot have been sold, with no similar event reported during the review period.Five items have been resterilized; of these, three have been sold to date.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 due to infection after about 1 month from primary.The patient had primary left knee surgery on (b)(6) 2026.On (b)(6) 2026, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and revised the moto s6 lm - h8 insert to a same size insert (mdr 2026-00482).Presently, on (b)(6) 2026, the patient came in due to continued signs of infection and the pathogen is unknown.The surgeon removed the moto femoral component and moto tibial tray from the primary surgery and removed the moto insert from the first revision and implanted antibiotic spacers to treat the infection.

• Brand Name: MOTO PARTIAL KNEE SYSTEM
• Common Device Name: MOTO MEDIAL E-CROSS TIBIAL INSERT S6 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: 25253485
• Report Number: 3005180920-2026-00506
• Device Sequence Number: 13398080
• Product Code: HSX
• UDI-Device Identifier: 07630345712103
• UDI-Public: 07630345712103
• Combination Product (Y/N): N
• PMA/510(K) Number: K213071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/22/2026

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.EIF6.08.LM
• Device Lot Number: 2314140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• 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: Required Intervention
• Patient Sex: Male