BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 21771466 · Received April 4, 2025

    Report

    Report Number
    3005180920-2025-00232
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10-MAR-2025. LOT 1901588: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-MAY-2019. EXPIRATION DATE: 19-MAY-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 FIVE AND A HALF YEARS AFTER THE IMPLANTATION OF A TOTAL HIP ARTHROPLASTY DUE TO STEM LOOSENING. AVAILABLE X-RAY IMAGES CLEARLY CONFIRM SIGNS OF STEM MOBILIZATION AND SUBSIDENCE. ASEPTIC LOOSENING IS A WELL-DOCUMENTED COMPLICATION FOLLOWING PRIMARY CEMENTLESS HIP ARTHROPLASTIES, THOUGH ITS EXACT CAUSES OFTEN REMAIN UNCLEAR. IN THIS CASE, WE DO NOT HAVE SUFFICIENT INFORMATION FOR DETERMINIG THE REASON FOR THE FAILURE. VISUAL INSPECTION: LOOKING AT THE STEM BODY SOME SPOTS OF WHITE FILM ARE VISIBLE ON STEM BODY. IT IS NOT POSSIBLE TO IDENTIFY IF THIS FILM IS HA OR BONE RESIDUAL, OR A COMBINED EFFECT. ABSORPTION OF HA FROM THE STEM BODY CAN INDICATE THAT METABOLIC ACTIVITY WAS TAKING PLACE AND THAT, PRESUMABLY, ADEQUATE BONE CONTACT WAS ACHIEVED AT THE TIME OF SURGERY. SOME SIGNS OF MINOR DAMAGE AND SCRATCHES ARE PRESENT ON THE NECK OF THE EXPLANTED STEM, WHICH IS LIKELY DUE TO THE REVISION SURGERY AND NOT RELEVANT TO THE REPORTED ISSUE. BASED ON THE ANALYSIS COMPLETED AND INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO IDENTIFY A ROOT CAUSE OF THE STEM LOOSENING REPORTED. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE 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 5 YEARS AND 5 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF STEM LOOSENING. THE STEM WAS NOT OSTEOINTEGRATED AND WAS REMOVED BY HAND DURING THE REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745080 AMISTEM H FEMORAL STEMS AMISTEM H CEMENTLESS STEM LATERALIZED SIZE 3 LZO MEDACTA INTERNATIONAL SA 01.18.143 1901588 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention