BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 6

    MDR report key: 16521454 · Received March 10, 2023

    Report

    Report Number
    3005180920-2023-00143
    Event Type
    Injury
    Date Received
    March 10, 2023
    Date of Event
    February 14, 2023
    Report Date
    March 10, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885556
    PMA / PMN Number
    K151531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16-FEB-2023: LOT 162764: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUN-2016. EXPIRATION DATE: 2021-06-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM 6 YEARS AND 2 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE STEM, HEAD, LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054959 MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 6 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.39.006 162764 07630030885556

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention