BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMS STEM

    MDR report key: 23579960 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01142
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630345701879
    PMA / PMN Number
    K203041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 OCTOBER 2025. STEM: SMS SOLID COLLARED 01.36.165 SMS COLLARED SOLID STEM LAT SIZE 5 (K203041) LOT 2349433: (B)(4) 2025 ITEMS MANUFACTURED AND RELEASED ON 07-MAY-2024. EXPIRATION DATE: 21-APR-2029. 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. BALL HEADS: MECTACER 01.29.214 MECTACER HEAD BIOLOX DELTA DIA.40 12/14-L (K112115) LOT 2304163: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAR-2023. EXPIRATION DATE: 23-FEB-2028. 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: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, THE PATIENT HAD PRIMARY LEFT HIP SURGERY USING A MEDACTA HEAD AND STEM. A COMPETITOR'S LINER WAS USED. ON 20 (B)(6) 2025, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD AND REVISED THE COMPETITOR LINER WITH A COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN DUE TO INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM WITH A MEDACTA HEAD AND STEM. THE SURGEON REVISED THE COMPETITOR LINER WITH A COMPETITOR LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644035 SMS STEM SMS COLLARED SOLID STEM LAT SIZE5 LZO MEDACTA INTERNATIONAL SA 01.36.165 2349433 07630345701879

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention