BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMS STEM

    MDR report key: 24004377 · Received January 8, 2026

    Report

    Report Number
    3005180920-2026-00022
    Event Type
    Injury
    Date Received
    January 8, 2026
    Date of Event
    December 23, 2025
    Report Date
    January 8, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630345701749
    PMA / PMN Number
    K203041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 DECEMBER 2025. STEM: SMS SOLID COLLARED 01.36.147 SMS COLLARED SOLID STEM STD SIZE 7 (K203041) LOT 2244073: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2023. EXPIRATION DATE: 05-MAR-2028. 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: ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67351 SMS STEM SMS COLLARED SOLID STEM STD SIZE7 LZO MEDACTA INTERNATIONAL SA 01.36.147 2244073 07630345701749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention