BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 6

    MDR report key: 18267224 · Received December 5, 2023

    Report

    Report Number
    3005180920-2023-00950
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    November 14, 2023
    Report Date
    December 5, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030885556
    PMA / PMN Number
    K151531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 NOVEMEBER 2023. LOT 173196: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JAN-2018. EXPIRATION DATE: 2022-12-12. 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

    AT ABOUT 5 YEARS AND 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH A COMPETITOR'S PRODUCTS 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
    2178694 STEM: MASTERLOC CEMENTLESS TI COATED STD STEM SIZE 6 HIP STEM LZO MEDACTA INTERNATIONAL SA 173196 07630030885556

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention