BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTO PARTIAL KNEE SYSTEM - MEDIAL

    MDR report key: 23437070 · Received October 31, 2025

    Report

    Report Number
    3005180920-2025-01051
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 3, 2025
    Report Date
    October 31, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896118
    PMA / PMN Number
    K162084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 OCTOBER 2025: MOTO PARTIAL KNEE 02.18.IF4.09.LM MOTO MEDIAL TIBIAL INSERT S4 LM - H9 (K162084) LOT 2349453: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 11-APR-2024. EXPIRATION DATE: 2029-03-26. 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. MOTO PARTIAL KNEE 02.18.TF4.LM MOTO MEDIAL TIBIAL TRAY S4 LM (K162084) MOTO PARTIAL KNEE 02.18.IF4.09.LM MOTO MEDIAL TIBIAL INSERT S4 LM - H9 (K162084) LOT 2409978: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2024. EXPIRATION DATE: 2029-05-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 8 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.18.TF4.LM MOTO MEDIAL TIBIAL TRAY S4 LM (K162084) LOT. 2415665: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 07-AUG-2024. EXPIRATION DATE: 2029-07-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY MEDACTA R&D KNEE PROJECT MANAGER: DURING A UNI KNEE ARTHROPLASTY PROCEDURE, THE SURGEON WAS UNABLE TO PROPERLY ENGAGE THE FIRST TIBIAL INSERT WITH THE TIBIAL TRAY. A SECOND INSERT WAS SUBSEQUENTLY ATTEMPTED, WITH THE SAME RESULT. A THIRD INSERT OF A DIFFERENT THICKNESS (8 MM) WAS SUCCESSFULLY ENGAGED AND IMPLANTED WITHOUT ISSUE. THE USE OF THE 8 MM LINER WAS DEEMED CLINICALLY APPROPRIATE. A VISUAL INSPECTION WAS PERFORMED ON THE TWO TIBIAL INSERTS THAT COULD NOT BE ENGAGED. THE POSTERIOR REGION OF BOTH INSERTS' LOCKING MECHANISMS EXHIBITED VISIBLE MECHANICAL DAMAGE, INCLUDING BENDING AND PLASTIC DEFORMATION. NO OTHER ABNORMALITIES WERE NOTED ON THE ARTICULATING SURFACE OR PERIPHERAL GEOMETRY OF THE COMPONENTS. BASED ON THE OBSERVED DEFORMATION, IT IS PRESUMED THAT DURING THE INITIAL ATTEMPT TO COUPLE THE INSERT WITH THE TIBIAL BASEPLATE, THE INSERT MAY NOT HAVE BEEN PROPERLY ALIGNED OR FULLY SEATED WITHIN THE TRAY. THE SUBSEQUENT APPLICATION OF FORCE UNDER MISALIGNMENT LIKELY CAUSED PERMANENT DAMAGE TO THE POSTERIOR LOCKING FEATURE, PREVENTING PROPER ENGAGEMENT ON FURTHER ATTEMPTS. A REVIEW OF THE PRODUCTION AND QUALITY RECORDS FOR THE AFFECTED LOTS IDENTIFIED NO MANUFACTURING NONCONFORMITIES. OTHER INSERTS FROM THE SAME PRODUCTION LOTS HAVE BEEN IMPLANTED WITHOUT REPORTED ISSUES OR RELATED COMPLAINTS. BASED ON THE RESULTS OF THE VISUAL INSPECTION AND AVAILABLE INFORMATION, THERE IS NO EVIDENCE INDICATING A MANUFACTURING DEFECT OR DEVICE MALFUNCTION. 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

    THE SURGEON ATTEMPTED TO INSERT THE LINER INTO THE TIBIAL TRAY, BUT IT DIDN'T LOCK SECURELY. A SECOND INSERT WAS USED; HOWEVER, IT ALSO FAILED TO LOCK PROPERLY. THE CAUSE OF THESE ISSUES REMAINS UNKNOWN. FINALLY, AN 8MM INSERT WAS SUCCESSFULLY FIXED, AND THE SURGERY WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE TOTAL SURGERY TIME WAS 2 HOURS, INCLUDING A 40-MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893995 MOTO PARTIAL KNEE SYSTEM - MEDIAL MOTO MEDIAL TIBIAL INSERT S4 LM - H9 HSX MEDACTA INTERNATIONAL SA 02.18.IF4.09.LM 2349453 07630030896118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male