BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4

    MDR report key: 12056288 · Received June 24, 2021

    Report

    Report Number
    3005180920-2021-00517
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    May 26, 2021
    Report Date
    June 24, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803215
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 JUNE 2021 : LOT 181829: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JUL-2018. EXPIRATION DATE: 2023-07-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD PRIMARY HIP SURGERY ON (B)(6) 2017. ON (B)(6) 2020, THE PATIENT CAME IN THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM (UNKNOWN CAUSE). THE SURGEON REVISED THE STEM, HEAD, AND LINER. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM 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
    959772 STEM: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 4 CEMENTLESS ANATOMICAL STEM LZO MEDACTA INTERNATIONAL SA 01.13.104L 181829 07630030803215

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention