BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H FEMORAL STEMS

    MDR report key: 24738820 · Received March 31, 2026

    Report

    Report Number
    3005180920-2026-00300
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    March 13, 2026
    Report Date
    March 31, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804083
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 MARCH 2026. STEM: AMISTEM H 01.18.132 AMISTEM-H STD. SIZE 2 (K093944) LOT 164600: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-OCT-2016. EXPIRATION DATE: 04-OCT-2021. 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. ROOT CAUSE: 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 9 YEARS AND 1 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN ASSOCIATED WITH A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA INDICATED. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGEON ALSO REVISED THE D 32 LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803024 AMISTEM H FEMORAL STEMS AMISTEM-H STD. SIZE 2 LZO MEDACTA INTERNATIONAL SA 01.18.132 164600 07630030804083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention