BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 3

    MDR report key: 13557546 · Received February 18, 2022

    Report

    Report Number
    3005180920-2022-00126
    Event Type
    Injury
    Date Received
    February 18, 2022
    Date of Event
    January 21, 2022
    Report Date
    February 18, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885525
    PMA / PMN Number
    K160289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 JANUARY 2022. LOT 1810313: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2019. EXPIRATION DATE: 2024-MAR-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. ABOUT 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY, 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
    467676 STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.39.003 1810313 07630030885525

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention