BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE SYSTEM - MEDIAL

    MDR report key: 24068438 · Received January 14, 2026

    Report

    Report Number
    3005180920-2026-00035
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    December 30, 2025
    Report Date
    January 14, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895555
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 2 JANUARY 2025. MOTO PARTIAL KNEE 02.18.002LM MOTO MEDIAL FEMORAL COMPONENT S2 LM (K162084) LOT 2335033: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2023. EXPIRATION DATE: 18-SEP-2028. 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.IF3.08.LM MOTO MEDIAL TIBIAL INSERT S3 LM - H8 (K162084) LOT 2337200: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2023. EXPIRATION DATE: 14-OCT-2028. 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 2405017: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAY-2024. EXPIRATION DATE: 25-APR-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. 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 ABOUT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AFTER TEARING THEIR ACL. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130624 MOTO PARTIAL KNEE SYSTEM - MEDIAL MOTO MEDIAL FEMORAL COMPONENT S2 LM HSX MEDACTA INTERNATIONAL SA 02.18.002LM 2335033 07630030895555

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention