BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54

    MDR report key: 15987326 · Received December 15, 2022

    Report

    Report Number
    3005180920-2022-00949
    Event Type
    Injury
    Date Received
    December 15, 2022
    Date of Event
    November 29, 2022
    Report Date
    December 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807787
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED (B)(6) 2022: LOT 120058: 66 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2012. EXPIRATION DATE: 2017-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 65 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 9 YEARS 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A MALPOSTIONED CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570167 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54 HIP CEMENTLESS SHELL LZO MEDACTA INTERNATIONAL SA 01.26.45.0054 120058 07630030807787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention