BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 46

    MDR report key: 15832739 · Received November 21, 2022

    Report

    Report Number
    3005180920-2022-00885
    Event Type
    Injury
    Date Received
    November 21, 2022
    Date of Event
    March 11, 2022
    Report Date
    November 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807749
    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 ON 07 NOVEMBER 2022: LOT 170078: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2017. EXPIRATION DATE: 2022-05-15. 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

    AT ABOUT 4 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796908 CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 46 HIP ACETABULAR CUP LZO MEDACTA INTERNATIONAL SA 01.26.45.0046 170078 07630030807749

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention