BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 24558194 · Received March 10, 2026

    Report

    Report Number
    3005180920-2026-00173
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 10, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885020
    PMA / PMN Number
    K170690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 FEB 2026. STEM: M-VIZION 01.22.105 DISTAL STEM D 16MM L 140MM STRAIGHT (K170690) LOT 2429917: 20 ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2025. EXPIRATION DATE: 15-JAN-2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. STEM: M-VIZION 01.22.429 PROXIMAL BODY D 24MM L 60MM LAT WITH HOLES (K201471) LOT 2010794: 40 ITEMS MANUFACTURED AND RELEASED ON 19-AUG-2021. EXPIRATION DATE: 22-JUL-2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. DURING PREPARATION OF THE FEMORAL CANAL IN TOTAL HIP ARTHROPLASTY (THA), A FEMORAL PERFORATION OCCURRED. THE COMPLICATION WAS IDENTIFIED ONLY AFTER WOUND CLOSURE, REQUIRING A REOPERATION. RADIOGRAPHIC IMAGES SUGGEST THAT THE ACETABULAR CUP MAY BE OVERSIZED AND POSSIBLY POSITIONED IN A SUBOPTIMAL ORIENTATION; HOWEVER, ADDITIONAL RADIOGRAPHIC PROJECTIONS WOULD BE NECESSARY TO PROPERLY ASSESS THE IMPLANT POSITIONING. FEMORAL PERFORATION IS A KNOWN POTENTIAL INTRAOPERATIVE COMPLICATION OF THA AND IS DESCRIBED IN THE INSTRUCTIONS FOR USE. BASED ON THE AVAILABLE INFORMATION, IT IS NOT PLAUSIBLE THAT THIS EVENT WAS CAUSED BY A DEFECTIVE OR MALFUNCTIONING DEVICE. ROOT CAUSE:FEMORAL PERFORATION IS A KNOWN POTENTIAL INTRAOPERATIVE COMPLICATION OF TOTAL HIP ARTHROPLASTY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT PRIMARY AND REVISION SURGERY ON THE SAME DAY. DURING THE PRIMARY PROCEDURE, THE SURGEON NOTED THAT THE BONE AND CEMENT APPEARED TO PUSH THE IMPLANT IN AN ANTEROLATERAL DIRECTION, THOUGH IT INITIALLY SEEMED ACCEPTABLE. AFTER SURGERY, WHILE THE PATIENT WAS IN THE POST-ANESTHESIA CARE UNIT, A POSTOPERATIVE X-RAY SHOWED THAT THE STEM HAD PERFORATED THE BONE. POOR BONE QUALITY WAS ALSO OBSERVED. ALL COMPONENTS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620636 M-VIZION FEMORAL REVISION SYSTEM DISTAL STEM Ø16MM L 140MM STRAIGHT LZO MEDACTA INTERNATIONAL SA 01.22.105 2429917 07630030885020

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Required Intervention