BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE MOBILITY LINER

    MDR report key: 21585870 · Received March 12, 2025

    Report

    Report Number
    3005180920-2025-00169
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    February 17, 2025
    Report Date
    March 12, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807244
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 FEBR 2025. LOT 1901454: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2019. EXPIRATION DATE: 2024-05-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 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

    AT 5 YEARS 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175012 DOUBLE MOBILITY LINER HC PE LINER 28 / DMD MEH MEDACTA INTERNATIONAL SA 01.26.2848MHC 1901454 07630030807244

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female Required Intervention