BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 21206283 · Received January 22, 2025

    Report

    Report Number
    3005180920-2024-01160
    Event Type
    Injury
    Date Received
    January 22, 2025
    Date of Event
    December 23, 2024
    Report Date
    January 22, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804106
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23-12-2024. LOT 163096: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-08-2016. EXPIRATION DATE: 2021-08-16. 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. CLINICAL EVALUATION: A REVISION SURGERY WAS PERFORMED APPROXIMATELY 8 YEARS AFTER THE PRIMARY IMPLANTATION OF A THA DUE TO STEM LOOSENING. THE AVAILABLE X-RAY IMAGES REVEAL RADIOLUCENT LINES AROUND THE PROXIMAL STEM, CORTICAL BONE THICKENING AROUND THE DISTAL STEM AND REREFACTION IN THE TROCHANTERIC REGIN. ASEPTIC LOOSENING IS A WELL-DOCUMENTED ADVERSE EVENT IN THE LITERATURE FOLLOWING PRIMARY CEMENTLESS HIP ARTHROPLASTIES, AND ITS CAUSES ARE OFTEN UNCLEAR. IN THIS CASE, THE SPECIFIC REASON FOR THE FAILURE CANNOT BE DETERMINED. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 8 YEARS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS AND THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842362 AMISTEM H FEMORAL STEMS STEM: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4 LZO MEDACTA INTERNATIONAL SA 01.18.134 163096 07630030804106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention