BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE SYSTEM

    MDR report key: 23462127 · Received November 4, 2025

    Report

    Report Number
    3005180920-2025-01059
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630345711908
    PMA / PMN Number
    K213071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 OCTOBER 2025: MOTO PARTIAL KNEE 02.18.EIF5.08.RM MOTO MEDIAL E-CROSS TIBIAL INSERT S5 RM - H8 (K213071) LOT 2408600: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2024. EXPIRATION DATE: 21-MAY-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. CONCLUSIONS: 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

    AFTER 3 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASH OUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2719613 MOTO PARTIAL KNEE SYSTEM E-CROSS TIBIAL INSERT FIX S5 RM - 8MM HSX MEDACTA INTERNATIONAL SA 02.18.EIF5.08.RM 2408600 07630345711908

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention