BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-VIZION INSERTER ROD

    MDR report key: 19403911 · Received May 28, 2024

    Report

    Report Number
    3005180920-2024-00358
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630040739221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 3 MAY 2024 LOT 2055643: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER THE INSERTER ROD IS BROKEN AT ON SIDE, THE SIDE THAT IS SUPPOSED TO BE SCREWED TO THE DISTAL STEM. THE THREADED ROD IS ALSO BROKEN IN THE SAME WAY, AT THE END OF THE THREADED PORTION, ON ONE EXTREMITY. THE CAUSE OF THE BREAKAGE WAS PROBABLY THE EXCESSIVE FORCE APPLIED TO THE INSTRUMENTS DURING THE EXTRACTION PHASE OF THE DISTAL STEM. THE EXCESSIVE EXTRACTION FORCE WAS NEEDED DUE TO THE FACT THAT THE SURGEON IMPACTED HARD THE STEM DOWN INTO THE FEMUR TRYING TO REACH A CERTAIN POSITION WITHOUT SUCCESS, SO THEN HE DECIDED TO REMOVE IT BUT IT WAS VERY DIFFICULT (THE BONE WAS SCLEROTIC). CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT DURING INDEX SURGERY THE DISTAL STEM Ø12MM L 180MM DID NOT REACH EXPECTED POSITION DUE TO SCLEROTIC BONE.THE SURGEON TRIED TO REMOVE THE DISTAL STEM TO REAM FURTHER BUT THE STEM WAS TOO STRONGLY FIXED INTO THE BONE AND FOR THIS REASON THE EXTRACTION DEVICES BROKE AND IT WAS NOT POSSIBLE TO REMOVE THE STEM. THEREFORE, THE OPERATION WAS COMPLETED WITH A LEG LENGTHENING OF 6MM. TRIAL STEM WAS NOT USED. ADDITIONAL INVOLVED DEVICES. BATCH REVIEW PERFORMED ON 3 MAY 2024 ON STEM: M-VIZION 01.22.131 DISTAL STEM Ø12MM L 180MM STRAIGHT (K191816) LOT. 2208012. LOT 2208012: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-SEP-2022. EXPIRATION DATE: 2027-AUG-23. 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. BATCH REVIEW PERFORMED ON 3 MAY 2024 ON M-VIZION 01.22.10.0141 THREADED ROD LOT. 2055642 LOT 2055642: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-APR-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE DISTAL STEM Ø12MM L 180MM WAS NOT PLACED DEEP ENOUGH DUE TO INSUFFICIENT REAMING. WHEN TRYING TO REMOVE THE DISTAL STEM TO REAM FURTHER, THE EXTRACTION DEVICES BROKE AND IT WAS NOT POSSIBLE TO REMOVE THE STEM. A 40MM PROXIMAL STEM AND AN XS HEAD FROM COMPETITOR HAVE BEEN IMPLANTED. THE OPERATION WAS COMPLETED WITH A LEG LENGTHENING OF 6MM. THE PATIENT BONE WAS VERY SCLEROTIC. TRIAL STEM NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676693 M-VIZION INSERTER ROD HIP SURGICAL INSTRUMENT LXH MEDACTA INTERNATIONAL SA 2055643 07630040739221

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other