BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 3

    MDR report key: 20310909 · Received September 26, 2024

    Report

    Report Number
    3005180920-2024-00776
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    August 21, 2024
    Report Date
    September 26, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 SEPTEMBER 2024 LOT 150141: 100 ITEMS MANUFACTURED AND RELEASED ON 28-APR-2015. EXPIRATION DATE: 2020-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 97 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: A REVISION SURGERY WAS PERFORMED APPROXIMATELY 9 YEARS AFTER THE PRIMARY IMPLANTATION OF A THA, WITH THE REPORTED CAUSE BEING ASEPTIC LOOSENING. THE AVAILABLE X-RAYS CONFIRM STEM LOOSENING, SHOWING RADIOLUCENCY LINES IN THE PROXIMAL FEMUR AND VISIBLE BONE RAREFACTION AT THE GREATER TROCHANTER. ASEPTIC LOOSENING IS A KNOWN ADVERSE EVENT DESCRIBED IN THE LITERATURE FOLLOWING PRIMARY CEMENTLESS HIP ARTHROPLASTIES, AND ITS CAUSES ARE OFTEN UNCLEAR. ALSO IN THIS CASE, THE EXACT REASON FOR THE FAILURE CANNOT BE DEFINITIVELY DETERMINED. ANALYSIS PERFORMED BY R&D MANAGER: LOOKING AT THE IMAGE ATTACHED TO THE COMPLAINT IT IS VISIBLE THE EXPIANTED STEM COVERED WITH PATIENT BLOOD. IT SEEMS THAT NO HA RESIDUALS ARE PRESENT ON THE STEM BODY BUT IT IS NOT POSSIBLE TO COFIRM THIS EVIDENCE FROM THE IMAGE. 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. THE POST-OP X-RAY ANALYSIS COULD POSSIBLY PROVIDE MORE INSIGHT, SUCH AS THE EVALUATION OF POSSIBLE EARLY ROTATIONAL INSTABILITY OR INITIAL STRESS-SHIELDING. 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.

    Description of Event or Problem · 0

    REVISION FOR STEM LOOSENING AT ABOUT 8 YEARS AND 11 MONTHS POST PRIMARY, THE REASON IS UNKNOWN. STEM AND INLAY EXCHANGE HAS BEEN PERFORMED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2264600 STEM: AMISTEM H HA COATED LAT STEM SIZE 3 HIP STEM LZO MEDACTA INTERNATIONAL SA 150141 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention