BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOULDER SYSTEM INSTRUMENT

    MDR report key: 21595089 · Received March 13, 2025

    Report

    Report Number
    3005180920-2025-00119
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 12, 2025
    Report Date
    March 13, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630971211896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2025. LOT 1957812: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6)2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION: THE IMPOSSIBILITY TO INSERT FREELY THE SCREW THROUGH THE GLENOSPHERE SUGGESTS THAT THE GLENOSPHERE WAS MALPOSITIONED ON THE BASEPLATE TAPER. THE FACT THAT NO GLENOSPHERE GUIDE WAS NOT USED MAY HAVE RESULTED IN AN INCORRECT ALIGNMENT OF THE TWO IMPLANTS. THE GLENOSPHERE SCREW WAS THEN HAMMERED INTO THE GLENOSPHERE RECESS, RESULTING IN THE SCREW GETTING STUCK. THIS IS CONFIRMED BY THE FACT THE A HIGH TORQUE APPLIED OF THE EXTRACTION INSTRUMENTS DID NOT LEAD TO THE DISENGAGEMENT OF THE IMPLANTS. THE GLENOSPHERE SCREW SHOWS CIRCULAR AREAS WHERE THE ANODIZATION IS REMOVED. THIS WAS DUE TO FRICTION WITH THE GLENOSPHERE RECESS AND BASEPLATE BORE WHILE ATTEMPTING TO TIGHTEN THE SCREW. THE GLENOSPHERE EXTRACTION SCREW APPEARS TO BE DEFORMED IN THE PICTURE. THE ROOT CAUSE OF SUCH A DEFORMATION CANNOT BE DETERMINED BUT MAY BE RELATED TO THE SPECIFIC SURGICAL APPLICATION. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON (B)(6) 2025 ON REVERSE SHOULDER SYSTEM 04.01.0173. GLENOSPHERE 39XØ27 (K170452) LOT. 2409932. LOT 2409932: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEPT-2024. EXPIRATION DATE: 2029-AUG-21. 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.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, THE SCREW OF THE GLENOSPHERE COULD NOT BE INSERTED PROPERLY. AFTER SEVERAL ATTEMPTS, THE SURGEON BECAME FRUSTRATED AND HAMMERED THE SCREW INTO THE GLENOSPHERE BUT WAS STILL UNABLE TO TIGHTEN IT. HE THEN DECIDED TO USE A NEW GLENOSPHERE AND ATTEMPTED TO REMOVE THE FIRST ONE FROM THE BASEPLATE USING THE DEDICATED INSTRUMENT. HOWEVER, DUE TO THE GLENOSPHERE BEING BLOCKED, EXCESSIVE FORCE WAS APPLIED, CAUSING THE INNER PART OF THE GLENOSPHERE EXTRACTION SCREW (REF (B)(4)) TO BEND. A NEW GLENOSPHERE 36XØ27 WAS USED, AND THE SURGERY WAS COMPLETED WITH ABOUT 30 MIN DELAY. GLENOSPHERE GUIDE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521962 SHOULDER SYSTEM INSTRUMENT SHOULDER GENERAL GLENOSPHERE EXTRACTION SCREW LXH MEDACTA INTERNATIONAL SA 04.01.10.0283 1957812 07630971211896

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other