BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP INSTRUMENTS

    MDR report key: 21717552 · Received March 28, 2025

    Report

    Report Number
    3005180920-2025-00239
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    February 17, 2025
    Report Date
    February 12, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630040738958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 MARCH 2025 LOT 2250125: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-SEP-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ONE SIMILAR EVENT HAS BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEM INVOLVED IN THE EVENT, STEM: M-VIZION 01.22.408 PROXIMAL BODY Ø20MM L 50MM LAT WITH HOLES LOT. 2409210 LOT 2409210: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09/09/2024. EXPIRATION DATE: 20/08/2029. 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. VISUAL INSPECTION THE DISASSEMBLY ROD WAS VISIBLY DEFORMED, A SIGN OF LOADING BEYOND THE MAXIMUM LOAD THE BAR COULD BEAR. THIS SITUATION CAN OCCUR WHEN THE MODULAR TAPER JUNCTION IS SO TIGHTENED THAT THE DISASSEMBLY TOOL CANNOT DISASSEMBLE THE TWO PARTS. IT IS UNCLEAR WHY THE MODULAR TAPER JUNCTION DISASSEMBLY FORCE WAS SO HIGH. IT IS PROBABLY BECAUSE THE STEM WAS IMPLANTED ONE MONTH BEFORE THE REVISION SURGERY, AND DURING THIS TIME, THE PATIENT'S WEIGHT FURTHER LOCKED THE MODULAR JUNCTION, LOADING IT DURING STANDING AND WALKING. STUDIES ARE ONGOING TO MINIMIZE THE OCCURRENCE OF THIS EVENT. ROOT CAUSE: THE CONDITIONS OF SURGICAL VARIATION LIKELY RESULTED IN THE APPLIED FORCES EXCEEDING THE INHERENT LIMITATIONS OF THE DEVICE RESISTANCE AS CONSTRAINED BY THE COLLECTIVE DESIGN INPUTS. THERE IS NO POTENTIAL MANUFACTURING RELATED CAUSE INDICATED.

    Description of Event or Problem · 0

    M-VIZION STEM WAS IMPLANTED ON (B)(6) 2025. THE PATIENT NEEDED TO BE REVISED BECAUSE WAS EXPERIENCING PAIN, INSTABILITY AND LEG LENGTH DISCREPANCY, DUE TO A TOO SHORT PROXIMAL BODY IMPLANTED AT THE PRIMARY SURGERY. THE REVISION SURGERY TOOK PLACE 1 MONTH AFTER THE PRIMARY SURGERY AND THE PLAN WAS TO REVISE ONLY THE PROXIMAL BODY (MDR 2025-00242). HOWEVER, THE DISASSEMBLY ROD BENT DURING PROXIMAL STEM EXTRACTION FROM THE DISTAL BODY. DESPITE THE ATTEMPTS, THE PROXIMAL BODY COULD NOT BE REMOVED FROM THE DISTAL STEM, THEREFORE THE SURGEON DECIDED TO REMOVE THE ENTIRE STEM (PROXIMAL + DISTAL). SURGERY WAS EXTENDED BY ABOUT 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407454 HIP INSTRUMENTS DISASSEMBLY ROD LXH MEDACTA INTERNATIONAL SA 01.22.10.0109 2250125 07630040738958

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other