BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTO PARTIAL KNEE SYSTEM - MEDIAL

    MDR report key: 22381164 · Received July 2, 2025

    Report

    Report Number
    3005180920-2025-00598
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 5, 2025
    Report Date
    July 16, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895975
    PMA / PMN Number
    K162084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 JUN 2025 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2023. EXPIRATION DATE: 2027-12-20. 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. ADDITIONAL DEVICES INVOLVED: MOTO PARTIAL KNEE 02.18.TF3.LM TIBIAL TRAY FIX CEMENTED S3 LM (K162084) LOT. 2429905 BATCH REVIEW PERFORMED ON 06 JUN 2025. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JAN-2025. EXPIRATION DATE: 2030-01-13. 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.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D DEPARTMENT: THE POSTERIOR REGION OF THE INSERT'S LOCKING MECHANISM APPEARS LIGHTLY DAMAGED, EXHIBITING SIGNS OF BENDING AND PLASTIC DEFORMATION. THE ANTERIOR ELASTIC LIP PRESENTS SIGNS OF PLASTIC DEFORMATION WITH A NEGATIVE SHAPE COMPATIBLE WITH THE PROFILE OF THE TIBIAL TRAY. IT IS PRESUMED THAT DURING THE INITIAL ATTEMPT TO ENGAGE THE INSERT WITH THE BASEPLATE, THE INSERT MAY NOT HAVE BEEN PROPERLY ALIGNED OR SEATED WITHIN THE TRAY. AS A RESULT, FORCE APPLIED DURING THIS ATTEMPT LIKELY CAUSED PERMANENT DAMAGE TO THE LOCKING FEATURE, THEREBY PREVENTING SUCCESSFUL ENGAGEMENT IN SUBSEQUENT ATTEMPTS. BASED ON THE VISUAL INSPECTION, THERE IS NO INDICATION THAT THE INCIDENT WAS CAUSED BY 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

    IT WAS NOT POSSIBLE TO COUPLE THE PE 8 MM INSERT WITH THE FIX CEMENTED TIBIAL TRAY. A NEW 9 MM INSERT WAS USED, BUT THE SAME PROBLEM OCCURRED. EVENTUALLY, THE SURGEON WAS ABLE TO SEAT THE LINER. DELAY 20 MIN, TOT SURGERY 90 MIN. NO RECUT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130734 MOTO PARTIAL KNEE SYSTEM - MEDIAL MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 LM - 8MM HSX MEDACTA INTERNATIONAL SA 02.18.IF3.08.LM 2240520 07630030895975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other