BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMS STEM

    MDR report key: 22402969 · Received July 4, 2025

    Report

    Report Number
    3005180920-2025-00620
    Event Type
    Injury
    Date Received
    July 4, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630345701879
    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 17-JUN-2025: LOT 2211325: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-10-2022 EXPIRATION DATE: 2027-10-03. 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. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY HIP 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 FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED STEM, HEAD, AND LINER AND ALSO IMPLANTED A DM COVERTER. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951015 SMS STEM SMS COLLARED SOLID STEM LAT SIZE 5 LZO MEDACTA INTERNATIONAL SA 01.36.165 2211325 07630345701879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention