BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMAX STEMS

    MDR report key: 23886580 · Received December 24, 2025

    Report

    Report Number
    3005180920-2025-01308
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    December 15, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803260
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 DECEMBER 2025. STEM: MINIMAX 01.13.106R MINIMAX STEM - SIZE 6 RIGHT (K170845) LOT 2338470: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2024. EXPIRATION DATE: 05-MAR-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. ROOT CAUSE: 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 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM. THE SURGEON REVISED THE STEM HEAD AND SLEEVE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058890 MINIMAX STEMS MINIMAX STEM - SIZE 6 RIGHT LZO MEDACTA INTERNATIONAL SA 01.13.106R 2338470 07630030803260

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention