BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SHELL DIAM 52

    MDR report key: 6127422 · Received November 25, 2016

    Report

    Report Number
    3005180920-2016-00619
    Event Type
    Injury
    Date Received
    November 25, 2016
    Date of Event
    October 28, 2016
    Report Date
    November 25, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 NOVEMBER 2016. (B)(4).

    Description of Event or Problem · 1

    REVISION SURGERY 4 MONTHS AFTER PRIMARY DUE TO MOBILIZATION OF THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778015 VERSAFITCUP CC TRIO ACETABULAR SHELL DIAM 52 ACETABULAR SHELL LZO MEDACTA INTERNATIONAL SA 157086

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention