BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMAX STEMS

    MDR report key: 21229329 · Received January 24, 2025

    Report

    Report Number
    3005180920-2025-00003
    Event Type
    Injury
    Date Received
    January 24, 2025
    Date of Event
    January 1, 2025
    Report Date
    January 24, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803222
    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 07 JANUARY 2025: LOT 2242470: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2023. EXPIRATION DATE: 2028-01-21. 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 MEDACTA CLINICAL AFFAIRS MANAGER: A REVISION SURGERY WAS PERFORMED THREE WEEKS AFTER THE PRIMARY IMPLANTATION OF A TOTAL HIP ARTHROPLASTY (THA). A FEMORAL FRACTURE WAS REPORTED; HOWEVER, WE HAVE NO EVIDENCE OF THIS, AS THE ONLY AVAILABLE X-RAY IMAGE PERTAINS TO THE IMMEDIATE POST-OPERATIVE PERIOD. THE REPORTED CAUSE OF THE FRACTURE WAS A TWISTING MOTION OF THE HIP. UNFORTUNATELY, WE ARE UNABLE TO PROVIDE A THOROUGH EVALUATION, AS THE AVAILABLE IMAGE REFERS TO THE POST-OPERATIVE AND IS OF VERY POOR QUALITY, MAKING THE BONE STRUCTURES DIFFICULT TO VISUALIZE.

    Description of Event or Problem · 0

    THE PATIENT HAD PAIN AFTER TWISTING THE HIP. NO PROBLEM WITH THE DEVICES. THE FEMUR FRACTURED. AT ABOUT 3 WEEKS FROM PRIMARY THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741035 MINIMAX STEMS MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SZE 4 LZO MEDACTA INTERNATIONAL SA 01.13.104R 2242470 07630030803222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention