BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER CERAMIC HEAD

    MDR report key: 10746079 · Received October 28, 2020

    Report

    Report Number
    3005180920-2020-00760
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    September 30, 2020
    Report Date
    October 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER: BASED ON THE EVENT DESCRIPTION, MEDACTA HEAD HAS BEEN COUPLED WITH A NON MEDACTA LINER. FROM THE PICTURES ATTACHED WE CANNOT STATE ANYTHING ABOUT THE EVENT AND WE CANNOT ESTABLISH A ROOT CAUSE. EXTENSIVE METAL TRANSFER ON A CERTAIN REGION OF THE FEMORAL HEAD IS VISIBLE. THE EVENT DESCRIPTION IS VERY SCARCE, THIS DOES NOT HELP WITH THE ANALYSIS. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: VERY SCARCE INFORMATION IS AVAILABLE FOR THIS CASE. APPARENTLY, A PROBLEM AROSE WITH THE ACETABULAR CUP (DIFFERENT MANUFACTURER) IN THIS 21-YEAR-OLD THA ON A VERY YOUNG WOMAN ((B)(6) AT THE TIME OF INDEX SURGERY). SUBSEQUENT TO THE ACETABULAR DAMAGE, THE CUP WAS REPLACED (NOT WITH MEDACTA PRODUCTS) AND, AS CUSTOMARY, THE CERAMIC HEAD WAS REPLACED. NO APPARENT DAMAGE TO THE FEMORAL HEAD TOOK PLACE OVER THE 21 YEARS OF SERVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN (PRIMARY SURGERY DATE UNKNOWN) DUE TO A DISLOCATION OF THE MEDACTA HEAD FROM A COMPETITOR LINER. THE SURGEON REVISED THE MEDACTA HEAD WITH A COMPETITOR HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213250 MECTACER CERAMIC HEAD HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention