BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE SYSTEM - MEDIAL

    MDR report key: 23615349 · Received November 21, 2025

    Report

    Report Number
    3005180920-2025-01138
    Event Type
    Injury
    Date Received
    November 21, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895579
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 NOV 2025. MOTO PARTIAL KNEE 02.18.003LM MOTO MEDIAL FEMORAL COMPONENT S3 LM (K162084) LOT 2317034: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2023. EXPIRATION DATE: 2028-AUG-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.18.IF3.08.LM MOTO MEDIAL TIBIAL INSERT S3 LM - H8 (K162084) LOT 2304564: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2023. EXPIRATION DATE: 2028-JUN-21. 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.TF3.LM MOTO MEDIAL TIBIAL TRAY S3 LM (K162084) LOT 2315388: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-SEPT-2023. EXPIRATION DATE: 2028-SEPT-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. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT 1 YEAR 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO STIFFNESS AND LACK OF FULL EXTENSION OF THE KNEE. THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE KNEE FROM A MOTO SYSTEM TO SPHERIKA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076219 MOTO PARTIAL KNEE SYSTEM - MEDIAL MOTO MEDIAL FEMORAL COMPONENT S3 LM HSX MEDACTA INTERNATIONAL SA 02.18.003LM 2317034 07630030895579

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention