BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMS STEM

    MDR report key: 22371286 · Received July 1, 2025

    Report

    Report Number
    3005180920-2025-00581
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 3, 2025
    Report Date
    July 1, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630345701886
    PMA / PMN Number
    K203041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06-JUNE-2025: LOT 2211327: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-10-2022 EXPIRATION DATE: 2027-10-11. 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. 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 7 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193665 SMS STEM SMS SOLID COLLARED STEM LAT SIZE 6 LZO MEDACTA INTERNATIONAL SA 01.36.166 2211327 07630345701886

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention