BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 3

    MDR report key: 19720351 · Received July 11, 2024

    Report

    Report Number
    3005180920-2024-00502
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    March 11, 2024
    Report Date
    July 11, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804090
    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 18 JUNE 2024. LOT 102808: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-OCT-2010. EXPIRATION DATE: 2015-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY (B)(4): REVISION 13 YEARS AND 4 MONTHS AFTER PRIMARY THA DUE TO STEM LOOSENING. THE PRIMARY WAS DONE WHEN THE PATIENT WAS 60 YEARS OLD, SO QUITE YOUNG. FROM THE RADIOGRAPHIC IMAGE SIGNS OF STRESS SHIELDING ARE VISIBLE. LONG TERM ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS HIP ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN, PARTICULARLY IN WOMEN AFTER MENOPAUSE. THE REASON OF THIS FAILURE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    REVISION DUE TO STEM LOOSENING AT ABOUT 13 YEARS AND 4 MONTHS POST PRIMARY. STEM, HEAD AND LINER REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340883 STEM: AMISTEM H HA COATED STD STEM SIZE 3 HIP FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 102808 07630030804090

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Required Intervention