BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY SHELLS

    MDR report key: 20522022 · Received October 24, 2024

    Report

    Report Number
    3005180920-2024-00868
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    September 25, 2024
    Report Date
    December 18, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030860973
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 2 OCTOBER 2024: LOT 2009457: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2021. EXPIRATION DATE: 2026-FEB-28. 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.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024 FWE HAVE RECEIVED THE DATE OF BIRTH OF THE PATIENT. ON (B)(6) 2024, IT WAS CONFIRMED ALSO THAT THE CUP IMPLANTED DURING THE FIRST REVISION WAS FROM COMPETITOR AND THAT THE PATIENT WAS REVISED AGAIN ON (B)(6) 2024 DUE TO COMPETITOR CUP IMPINGEMENT. DETAILS ADDED IN THE FOLLOW-UP: PATIENT DATE OF BIRTH: (B)(6) 1962. EVENT DESCRIPTION.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN. UPON EXPLORATION, THE SURGEON OBSERVED POOR CUP PLACEMENT. ABOUT 3 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE CUP, LINER AND HEAD. CUP WAS WELL FIXED, IT WAS PROBABLY MALPOSITIONED DURING PRIMARY, BUT THIS CANNOT BE CONFIRMED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN. UPON EXPLORATION, THE SURGEON OBSERVED POOR CUP PLACEMENT. ABOUT 3 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE CUP AND LINER WITH COMPETITOR COMPONENTS AND HEAD WITH MEDACTA HEAD. CUP WAS WELL FIXED, IT WAS PROBABLY MALPOSITIONED DURING PRIMARY, BUT THIS CANNOT BE CONFIRMED. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT WAS REVISED AGAIN DUE TO COMPETITOR'S CUP MALPOSITIONING (MALPOSITIONED CUP CAUSING IMPINGEMENT ON THE TRUNNION), AND THE MEDACTA HEAD WAS REVISED AS PER STANDARD PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565899 MPACT DOUBLE MOBILITY SHELLS HIP CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL SA 01.32.152MB 2009457 07630030860973

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Required Intervention