BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE SYSTEM

    MDR report key: 24964776 · Received April 23, 2026

    Report

    Report Number
    3005180920-2026-00355
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 23, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630345711694
    PMA / PMN Number
    K213071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2026 MOTO PARTIAL KNEE 02.18.EIF4.08.RM MOTO MEDIAL E-CROSS TIBIAL INSERT S4 RM - H8 (K213071), LOT 2500621: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2025. EXPIRATION DATE: 09-03-2030. 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.

    Description of Event or Problem · 0

    AT ABOUT 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE S4 - H8 MOTO INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026715 MOTO PARTIAL KNEE SYSTEM MOTO MEDIAL E-CROSS TIBIAL INSERT S4 RM - H8 HSX MEDACTA INTERNATIONAL SA 02.18.EIF4.08.RM 2500621 07630345711694

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention