BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50

    MDR report key: 18578386 · Received January 25, 2024

    Report

    Report Number
    3005180920-2024-00001
    Event Type
    Injury
    Date Received
    January 25, 2024
    Date of Event
    January 2, 2024
    Report Date
    January 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807763
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 JANUARY 2024: LOT 132202: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2013. EXPIRATION DATE: 2018-05-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 10 YEARS AND 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140878 VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50 ACETABULAR CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL SA 132202 07630030807763

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention