BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM COLLARED HA COATED LAT STEM SIZE 3

    MDR report key: 20341696 · Received October 1, 2024

    Report

    Report Number
    3005180920-2024-00769
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    September 3, 2024
    Report Date
    October 1, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804687
    PMA / PMN Number
    K121011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 SEP 2024. LOT 180792: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUNE-2018. EXPIRATION DATE: 2023-06-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: A REVISION SURGERY WAS PERFORMED ONE AND A HALF YEARS AFTER THE PRIMARY IMPLANTATION OF A TOTAL HIP ARTHROPLASTY (THA). THE REPORTED REASON FOR THE REVISION WAS STEM LOOSENING. THE AVAILABLE X-RAY IMAGE CLEARLY SHOWS RADIOLUCENT LINES IN THE PROXIMAL PART OF THE FEMORAL STEM, BOTH MEDIALLY AND LATERALLY. DETERMINING THE CAUSE OF THIS FAILURE IS CHALLENGING WITH THE INFORMATION CURRENTLY AVAILABLE. ASEPTIC LOOSENING IS A WELL-DOCUMENTED COMPLICATION FOLLOWING THA, AND ITS CAUSES ARE OFTEN UNKNOWN. ADDITIONALLY, THE IMAGE SHOWS FIXATION IMPLANTS FOR A PELVIC FRACTURE. THE TIMING OF THIS FRACTURE IS NOT REPORTED, AND IT IS UNCLEAR WHETHER IT MAY HAVE CONTRIBUTED TO THE PROSTHETIC FAILURE. AT THIS POINT, WE DO NOT HAVE SUFFICIENT INFORMATION TO SUSPECT A DEFECTIVE OR MALFUNCTIONING DEVICE.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS 7 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO STEM LOOSENING. ALL COMPONENTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35484 STEM COLLARED HA COATED LAT STEM SIZE 3 HIP STEM LZO MEDACTA INTERNATIONAL SA 180792 07630030804687

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention