BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMS STEM

    MDR report key: 22714426 · Received August 5, 2025

    Report

    Report Number
    3005180920-2025-00730
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 5, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030888854
    PMA / PMN Number
    K181693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22-07-2025. STEM: SMS SOLID 01.36.073 SMS SOLID STEM LAT SIZE 13 (K181693) LOT 1903494: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-07-2019 EXPIRATION DATE: 2024-06-24. 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. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT: REVISION SURGERY WAS PERFORMED APPROXIMATELY ONE YEAR AFTER THE PRIMARY TOTAL HIP ARTHROPLASTY (THA) DUE TO STEM LOOSENING. THE PATIENT HAD REPORTED PAIN AND UNDERWENT RADIOLOGICAL FOLLOW-UP. THE AVAILABLE X-RAY IMAGES CONFIRM STEM MOBILIZATION, WITH RADIOLUCENT LINES PARTICULARLY EVIDENT AROUND THE SHOULDER OF THE STEM. ASEPTIC LOOSENING IS A WELL-DOCUMENTED COMPLICATION IN THE LITERATURE, OFTEN WITH MULTIFACTORIAL OR UNCLEAR ETIOLOGY. EVEN IN THIS CASE, THE PRECISE CAUSE OF THE FAILURE REMAINS DIFFICULT TO DETERMINE BASED ON THE AVAILABLE INFORMATION. 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 AND 2 MONTHS FROM 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
    2684762 SMS STEM SMS SOLID STEM LAT SIZE 13 LZO MEDACTA INTERNATIONAL SA 01.36.073 1903494 07630030888854

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention