BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE SYSTEM - MEDIAL

    MDR report key: 25039925 · Received April 30, 2026

    Report

    Report Number
    3005180920-2026-00369
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 30, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895609
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 29 APRIL 2026: MOTO PARTIAL KNEE 02.18.004RM MOTO MEDIAL FEMORAL COMPONENT S4 RM (K162084) LOT 2417069: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2024. EXPIRATION DATE: 2029-SEP-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. 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-SEP-2024. EXPIRATION DATE: 2029-MAY-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.18.TF5.RM MOTO MEDIAL TIBIAL TRAY S5 RM (K162084) LOT 2415666: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-SEP-2024. EXPIRATION DATE: 2029-JUL-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS 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

    THE PATIENT HAD SIGNS OF KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 9 MONTHS POST PRIMARY THE SURGEON REMOVED ALL MOTO IMPLANTS (FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY) AND PLACED ANTIBIOTIC SPACERS UNTIL PERMANENT HARDWARE IS IMPLANTED IN A FUTURE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622106 MOTO PARTIAL KNEE SYSTEM - MEDIAL MOTO MEDIAL FEMORAL COMPONENT S4 RM HSX MEDACTA INTERNATIONAL SA 02.18.004RM 2417069 07630030895609

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention