BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMAX STEMS

    MDR report key: 21591415 · Received March 13, 2025

    Report

    Report Number
    3005180920-2025-00204
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    February 20, 2025
    Report Date
    March 13, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803185
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 MARCH 2025. LOT 1902970: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2019. EXPIRATION DATE: 2024-06-25. 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. 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

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. ON (B)(6) 2024, THE SURGEON REVISED THE MEDACTA STEM, HEAD AND LINER WITH ANOTHER MEDACTA STEM, HEAD AND LINER. PRESENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S COMPONENTS AND REVISED THE MEDACTA LINER WITH ANOTHER MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822708 MINIMAX STEMS CEMENTLESS ANATOMICAL STEM RIGHT SIZE 2 LZO MEDACTA INTERNATIONAL SA 01.13.102R 1902970 07630030803185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention