BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 20817086 · Received December 2, 2024

    Report

    Report Number
    3005180920-2024-01003
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    November 8, 2024
    Report Date
    December 2, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630971263529
    PMA / PMN Number
    K201471
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 NOVEMBER 2024. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2024. EXPIRATION DATE: 2028-JUL-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 7 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED: LINER: VERSAFITCUP CC TRIO 01.26.2852MHC DOUBLE MOBILITY HC LINER Ø 52/28 K092265 LOT. 2346561 BATCH REVIEW PERFORMED ON 15 NOVEMBER 2024. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUL-2023. EXPIRATION DATE: 2029-JAN-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 65 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.230H HEAD BIOLOX OPTION Ø 28 K131518 LOT. 2343520. BATCH REVIEW PERFORMED ON 15 NOVEMBER 2024. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2023. EXPIRATION DATE: 2028-NOV-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.243A SLEEVE SIZE XL K131518 LOT. 2345153. BATCH REVIEW PERFORMED ON 15 NOVEMBER 2024. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-DEC-2023. EXPIRATION DATE: 2028-DEC-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: A RE-REVISION SURGERY OF A TOTAL HIP ARTHROPLASTY WAS PERFORMED DUE TO INFECTION. THE AVAILABLE X-RAY IMAGE REVEALS BONE ALTERATIONS IN THE PROXIMAL FEMUR, WITH RAREFACTION PARTICULARLY EVIDENT IN THE GREATER TROCHANTER REGION. THESE FINDINGS CAN BE INTERPRETED AS INDIRECT SIGNS OF THE REPORTED INFECTION. INFECTION IS A RECOGNIZED POTENTIAL ADVERSE EVENT FOLLOWING ANY SURGICAL PROCEDURE, ESPECIALLY IN CASES OF REVISION SURGERY. AT PRESENT, THERE IS NO EVIDENCE TO SUGGEST THAT THE IMPLANTED DEVICES ARE LINKED TO THE CAUSE OF THE INF. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2023; HEMIARTHROPLASTY WAS PROBABLY IMPLANTED. ON (B)(6) 2024, THE PATIENT WAS PROBABLY CONVERTED FROM HEMI TO TOTAL. ON (B)(6) 2024, THE PATIENT WAS REVISED DUE TO INFECTION. HEAD, LINER, AND PROXIMAL PART OF THE FEMORAL COMPONENT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304685 M-VIZION FEMORAL REVISION SYSTEM STEM: M-VIZION PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES LZO MEDACTA INTERNATIONAL SA 01.22.403 2304281 07630971263529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention