BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-VIZION PROXIMAL BODY HANDLE

    MDR report key: 18993010 · Received March 28, 2024

    Report

    Report Number
    3005180920-2024-00163
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    February 27, 2024
    Report Date
    March 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630040739252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 4 MARCH 2024 LOT 2155926: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 1 OTHER SIMILAR EVENT HAS BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: THE PROXIMAL BODY HANDLE 01.22.10.0151 DEFORMED DUE TO THE HIGH FORCE APPLIED TO THE INSTRUMENT DURING THE DISASSEMBLY PHASE. PROBABLY THE FORCE REQUIRED TO DISASSEMBLY THE PROXIMAL BODY FROM THE DISTAL STEM WAS HIGHER THAN EXPECTED DUE TO THE FACT THAT THE IMPLANT STAYED IN THE PATIENT 60 DAYS SO THE MODULAR CONNECTION WAS LOADED WITH THE PATIENT WEIGHT, FURTHER BLOCKING THE CONNECTION. ADDITIONAL INVOLVED DEVICES BATCH REVIEW PERFORMED ON 4 MARCH 2024 ON M-VIZION 01.22.10.0109 DISASSEMBLY ROD LOT. 2055090 LOT 2055090: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-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. BATCH REVIEW PERFORMED ON 4 MARCH 2024 ON M-VIZION 01.22.10.0109 DISASSEMBLY ROD LOT. 2155067 LOT 2155067: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOV-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. BATCH REVIEW PERFORMED ON 4 MARCH 2024 ON STEM: M-VIZION 01.22.023 PROXIMAL BODY Ø24MM L 60MM STD (K191816) LOT. 1901179 LOT 1901179: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2019. EXPIRATION DATE: 2024-NOV-16. 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 A REVISION SURGERY (DUE TO THE DISLOCATION OF THE BIPOLAR HEAD FROM THE ACETABULAR), AFTER COMPLETING THE ACETABULAR WORK, THE SURGEON ATTEMPTED TO DISASSEMBLE THE PROXIMAL BODY FROM THE DISTAL STEM, BECAUSE HE WANTED TO REVISE ALSO THE PROXIMAL STEM TO GIVE MORE STABILITY TO THE ARTICULATION. THE PROXIMAL BODY COULD NOT BE DISASSEMBLED AND THE DISASSEMBLY ROD AND THE PROXIMAL BODY HANDLE WERE DEFORMED. FOLLOWING THIS ATTEMPT, THEY USED THE BACKUP HANDLE AND ANOTHER DISASSEMBLY ROD, AND AGAIN THE COMPONENTS COULDN'T BE UNCOUPLED. AT THIS POINT, THEY ATTEMPTED TO BACK OFF THE BODY WITH THE STEM REMOVAL INSTRUMENTS BUT IT WOULD NOT RELEASE. THE SURGEON THEN DECIDED TO LEAVE THE M-VIZION STEM. ONLY 5 MINUTES DELAY REPORTED. THE SURGEON WAS SATISFIED WITH THE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724645 M-VIZION PROXIMAL BODY HANDLE HIP SURGICAL INSTRUMENT LXH MEDACTA INTERNATIONAL SA 2155926 07630040739252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other