BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMS STEM

    MDR report key: 24711051 · Received March 30, 2026

    Report

    Report Number
    3005180920-2026-00255
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 4, 2026
    Report Date
    March 27, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030888700
    PMA / PMN Number
    K181693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 MARCH 2026: LOT 2001928: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2020. EXPIRATION DATE: 2025-MAY-27. 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

    REVISION SURGERY DUE TO STEM LOOSENING ABOUT 3 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY.THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD. THE SURGEON ALSO REVISED THE MEDACTA LINER TO A SAME SIZE MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774199 SMS STEM SMS SOLID STEM STD SIZE11 LZO MEDACTA INTERNATIONAL SA 01.36.051 2001928 07630030888700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention