BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE SYSTEM - MEDIAL

    MDR report key: 24871678 · Received April 14, 2026

    Report

    Report Number
    3005180920-2026-00309
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 14, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895586
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 APRIL 2026 MOTO PARTIAL KNEE 02.18.003RM MOTO MEDIAL FEMORAL COMPONENT S3 RM (K162084) LOT. 2407825 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2024. EXPIRATION DATE: 02-MAY-2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 35 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.18.TF3.RM MOTO MEDIAL TIBIAL TRAY S3 RM (K162084) LOT. 2422900 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2024. EXPIRATION DATE: 09-OCT-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. MOTO PARTIAL KNEE 02.18.EIF3.08.RM MOTO E-CROSS TIBIAL INSERT S3 H8 RM (K213071) LOT. 2426262. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2024. EXPIRATION DATE: 22-OCT-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: 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

    REVISION SURGERY PERFORMED DUE TO INFECTION, 9 MONTHS AFTER THE PREVIOUS REVISION DUE TO INFECTION (MDR 2025-00628). THE SURGEON REMOVED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY, AND IMPLANTED ANTIBIOTIC SPACERS IN THE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933513 MOTO PARTIAL KNEE SYSTEM - MEDIAL MOTO MEDIAL FEMORAL COMPONENT S3 RM HSX MEDACTA INTERNATIONAL SA 02.18.003RM 2407825 07630030895586

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention