BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 19873011 · Received July 31, 2024

    Report

    Report Number
    3005180920-2024-00567
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    July 9, 2024
    Report Date
    July 31, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 JULY 2024. LOT 120916: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUNE-2012. EXPIRATION DATE: 2017-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. AT ABOUT 11 YEARS 6 MONTHS POST-PRIMARY THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983287 STEM: AMISTEM H HA COATED STD STEM SIZE 1 HIP FEMORAL STEM LZO MEDACTA INTERNATIONAL SA 120916

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention