BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTO PARTIAL KNEE SYSTEM - MEDIAL

    MDR report key: 22467161 · Received July 10, 2025

    Report

    Report Number
    3005180920-2025-00644
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 12, 2025
    Report Date
    October 2, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895852
    PMA / PMN Number
    K162084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 JUN 2025. LOT: 2407829: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2024. EXPIRATION DATE: 2029-05-14. 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. OTHER DEVICE INVOLVED: MOTO PARTIAL KNEE 02.18.TF2.LM TIBIAL TRAY FIX CEMENTED S2 LM (K162084), LOT: 2430922: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2025. EXPIRATION DATE: 2030-01-26. 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 NOT YET AVAILABLE.

    Additional Manufacturer Narrative · 0

    DEVICE NOT AVAILABLE. ROOT CAUSE: ALTHOUGH NO ROOT CAUSE CAN BE CONFIRMED FOR THIS CASE, IT IS MOST LIKELY THAT IN THE FIRST ATTEMPTS TO FIX THE INSERT INTO THE BASEPLATE, THE INSERT WAS NOT WELL POSITIONED AND BECAME DAMAGED, PRECLUDING THE POSSIBILITY TO FIX THE INSERT IN THE FOLLOWING ATTEMPTS. THE INVESTIGATION DOES NOT INDICATE A POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

    Description of Event or Problem · 0

    IT WAS NOT POSSIBLE TO COUPLE THE PE 8 MM INSERT WITH THE FIX CEMENTED TIBIAL TRAY. A NEW 9 MM INSERT WAS USED INSTEAD. SURGERY COMPLETED WITH 20 MIN DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773885 MOTO PARTIAL KNEE SYSTEM - MEDIAL MOTO PARTIAL KNEE 02.18.IF2.08.LM TIBIAL INSERT FIX S2 LM - 8MM HSX MEDACTA INTERNATIONAL SA 02.18.IF2.08.LM 2407829 07630030895852

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other