BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: SMS SOLID STEM STD SIZE 4

    MDR report key: 18018914 · Received October 27, 2023

    Report

    Report Number
    3005180920-2023-00782
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    September 28, 2023
    Report Date
    October 27, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030888632
    PMA / PMN Number
    K181693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 OCTOBER 2023: LOT 2001919: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2020. EXPIRATION DATE: 2025-05-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A NEW MEDACTA STEM AND HEAD AND REVISED THE CUP AND LINER WITH A COMPETITOR CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910636 STEM: SMS SOLID STEM STD SIZE 4 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 2001919 07630030888632

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention