BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-VIZION FEMORAL REVISION SYSTEM

    MDR report key: 23063081 · Received September 16, 2025

    Report

    Report Number
    3005180920-2025-00900
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    August 26, 2025
    Report Date
    September 16, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040728904
    PMA / PMN Number
    K191816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 03 SEPTEMBER 2025: STEM: M-VIZION 01.22.132 DISTAL STEM Ø13MM L 180MM STRAIGHT (K191816) LOT: 2303781: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-NOV-2023. EXPIRATION DATE: 2028-10-10. 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 DEVICES INVOLVED: STEM: M-VIZION 01.22.403 PROXIMAL BODY Ø20MM L 60MM STD WITH HOLES (K201471) LOT: 2115467: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2022. EXPIRATION DATE: 2027-03-06. 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. BALL HEADS: MECTACER 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 (K112115) LOT: 2430510: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2024. EXPIRATION DATE: 2029-NOV-03. 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. LINER: MPACT 01.32.3648HCT MPACT FLAT LINER HC 36/F L (K103721) LOT: 2415572: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2024. EXPIRATION DATE: 2029-06-03. 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. CUP: MPACT 3D METAL 01.38.356MH MPACT 3D METAL SHELL MULTI HOLE THIN Ø56MM (K202568) LOT: 2212482: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 4-AUG-2022. EXPIRATION DATE: 2027-07-17. 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. SCREWS: MPACT 01.43.0030 CANCELLOUS BONE SCREW Ø 6,5 L30 (K200391) LOT: 2417197: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUL-2024. EXPIRATION DATE: 2029-07-03. 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. SCREWS: MPACT 01.43.0030 CANCELLOUS BONE SCREW Ø 6,5 L30 (K200391) LOT: 2423374: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2024. EXPIRATION DATE: 2029-09-11. 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. CONCLUSIONS: 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

    THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 6 MONTHS FROM THE PRIMARY THE SURGEON PERFORMED A WASH OUT, AND REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC HIP SPACER. THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286593 M-VIZION FEMORAL REVISION SYSTEM DISTAL STEM Ø13MM L 180MM STRAIGHT LZO MEDACTA INTERNATIONAL SA 01.22.132 01.22.132 07630040728904

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention