BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM C CEMENTED STD SIZE 2

    MDR report key: 11272378 · Received February 3, 2021

    Report

    Report Number
    3005180920-2021-00076
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    January 4, 2021
    Report Date
    February 3, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804274
    PMA / PMN Number
    K103189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 15 JANUARY 2021: LOT 163117: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JULY-2016. EXPIRATION DATE: 2021-06-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2017

    Description of Event or Problem · 1

    ON (B)(6) 2021 (4 YEARS AFTER FIRST REVISION DUE TO PAIN PERFORMED ON (B)(6) 2017; STEM AND HEAD REVISED), THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED. SUCCESSFULLY. THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167585 STEM: AMISTEM C CEMENTED STD SIZE 2 FEMORAL CEMENTED STEM LZO MEDACTA INTERNATIONAL SA 01.18.152 163117 07630030804274

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention