BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO CEMENTLESS CUP

    MDR report key: 3870154 · Received May 28, 2014

    Report

    Report Number
    3006639916-2014-00062
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHEN THE SURGEON INITIALLY IMPLANTED THE CUP, HE IMPLANTED IT WITH TOO MUCH ANTIVERSION CAUSING THE HIP TO DISLOCATE MULTIPLE TIMES. THE PATIENT IS UNDERGOING A REVISION SURGERY TO CHANGE THE CUP AND LINER. REFERENCE MFR # 3005180920-2014-00062.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314240 VERSAFITCUP CC TRIO CEMENTLESS CUP ACETABULAR CEMENTLESS SHELL 58 LZO MEDACTA INTERNATIONAL SA 125508

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CODE 01.26.3648HCT - LOT. 134671| VERSAFITCUP CC LINER 36 F (K103352)