BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 22175023 · Received June 10, 2025

    Report

    Report Number
    3005180920-2025-00515
    Event Type
    Injury
    Date Received
    June 10, 2025
    Date of Event
    May 12, 2025
    Report Date
    June 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971263581
    PMA / PMN Number
    K201471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: A RE-REVISION PROCEDURE WAS PERFORMED FIVE MONTHS AFTER THE INITIAL REVISION SURGERY, DUE TO EVIDENCE OF STEM MOBILIZATION AND SUBSIDENCE. THE PRE-REVISION RADIOGRAPH, BEING A MODIFIED IMAGE INTENDED FOR SURGICAL PLANNING, OFFERS LIMITED VALUE FOR DETAILED CLINICAL ASSESSMENT. NEVERTHELESS, STEM SUBSIDENCE APPEARS TO BE CONFIRMED. THE IMMEDIATE POST-OPERATIVE RADIOGRAPH, ALTHOUGH OF SUBOPTIMAL QUALITY, DOES NOT REVEAL ANY OBVIOUS COMPLICATIONS; NOTABLY, THE DISTAL FIXATION OF THE STEM BEYOND THE FRACTURE SITE APPEARS ADEQUATE. IDENTIFYING THE PRECISE CAUSE OF FAILURE REMAINS DIFFICULT BASED ON THE AVAILABLE DATA. HOWEVER, THE POOR BONE QUALITY OBSERVED IN THE IMAGES MAY HAVE CONTRIBUTED TO THE OUTCOME. AT THIS STAGE, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN. BATCH REVIEW PERFORMED ON 16 MAY 2025: LOT 2347471: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07/05/2024. EXPIRATION DATE: 23/04/2029. 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. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 16 MAY 2025: STEM: M-VIZION 01.22.501 DISTAL STEM Ø12MM L 140MM STRAIGHT 4 DEGREE (K092076) LOT 2103669: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20/08/2021. EXPIRATION DATE: 29/06/2026. 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. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, ALTHOUGH IT IS POSSIBLE THAT FACTORS SUCH AS LOW BONE QUALITY MAY HAVE CONTRIBUTED TO THE EVENT. ALTHOUGH NO ROOT CAUSE CAN BE CONFIRMED, THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

    Description of Event or Problem · 0

    ABOUT 5 MONTHS AFTER THE FIRST REVISION SURGERY, ANOTHER REVISION SURGERY WAS PERFORMED DUE TO SECONDARY MOVEMENT AND SUBSIDENCE. THE PATIENT HAS A FIRST REVISION SURGERY (ON (B)(6) 2025) DUE TO A PERIPROSTHETIC FEMORAL FRACTURE CAUSED BY A FALL (PRIMARY SURGERY WAS PERFORMED IN (B)(6) 2013). PSEUDOARTHROSIS OF THE FRACTURE BORDERS IS CURRENTLY PRESENT, ESPECIALLY AROUND THE GREATER TROCHANTER AND ISTMUS REGION OF THE FEMUR. M-VIZION STEM REMOVED WITHOUT FURTHER DIFFICULTIES AND REPLACED WITH COMPETITOR REVISION SHAFT (CORAIL REVISION), PARTIAL REOPENING OF FRACTURE AREA, NEW CERCLAGES, AND PROXIMAL FEMORAL PLATE PLACED TO STABILIZE THE FRACTURE AROUND THE ISTHMUS AND GREATER TROCHANTER. VERSAFIT DM CUP IS STABLE AND HAS GOOD PLACEMENT IN THE ACETABULUM, SO IT WAS LEFT IN SITU. LINER AND HEAD REPLACED WITH THE SAME SIZES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355413 M-VIZION FEMORAL REVISION SYSTEM M-VIZION PROXIMAL BODY Ø20MM L 60MM LAT WITH HOLES LZO MEDACTA INTERNATIONAL SA 01.22.409 2347471 07630971263581

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention