BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: M-VIZION DISTAL STEM Ø15MM L 140MM STRAIGHT

    MDR report key: 18985247 · Received March 27, 2024

    Report

    Report Number
    3005180920-2024-00152
    Event Type
    Injury
    Date Received
    March 27, 2024
    Date of Event
    February 28, 2024
    Report Date
    March 27, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885013
    PMA / PMN Number
    K170690
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 6 MARCH 2024. LOT: 2007038: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2021. EXPIRATION DATE: 2025-DEC-08. 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 INVOLVED IMPLANTS. BATCH REVIEW PERFORMED ON 6 MARCH 2024 ON STEM: M-VIZION 01.22.401 PROXIMAL BODY Ø20MM L 40MM STD WITH HOLES (K201471) LOT. 2115466. LOT: 2115466: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAR-2022. EXPIRATION DATE: 2027-FEB-27. 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. BATCH REVIEW PERFORMED ON 6 MARCH 2024 ON BALL HEADS: COCR 01.25.014 COCR BALL HEAD 12/14 Ø 28 SIZE XL +7 (K072857) LOT. 1903463. LOT: 1903463: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-OCT-2019. EXPIRATION DATE: 2024-SEP-25. 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.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED COMPETITOR CUP AND LINER AND MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT CAME DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MEDACTA HEAD AND COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE MEDACTA STEM AND HEAD AND COMPETITOR CUP AND LINER AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2060828 STEM: M-VIZION DISTAL STEM Ø15MM L 140MM STRAIGHT HIP DISTAL STEM LZO MEDACTA INTERNATIONAL SA 2007038 07630030885013

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention