BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMS STEM

    MDR report key: 23461660 · Received November 4, 2025

    Report

    Report Number
    3005180920-2025-01029
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 4, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630345701718
    PMA / PMN Number
    K203041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 OCTOBER 2025: STEM: SMS SOLID COLLARED 01.36.144 SMS COLLARED SOLID STEM STD SIZE 4 (K203041) LOT. 2218145: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2022. EXPIRATION DATE: 05-DEC-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 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

    AFTER 1 YEAR AND 5 MONTHS, THE PATIENT PRESENTED WITH PAIN OF UNKNOWN CAUSE. THE SURGEON DETERMINED THERE WAS ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND REVISED THE HEAD AND LINER, UPSIZING THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2720532 SMS STEM SMS COLLARED SOLID STEM STD #4 LZO MEDACTA INTERNATIONAL SA 01.36.144 2218145 07630345701718

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention