BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP DM ACETABULAR CUP 54

    MDR report key: 3870150 · Received May 23, 2014

    Report

    Report Number
    3006639916-2014-00061
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS COMPLAINING OF PAIN. THE SURGEON DETERMINED THE CUP HAD MIGRATED SUPERIORLY AND ANTERIORLY: CUP AND LINER HAVE BEEN REVISED. REFERENCE MFR # 3005180920-2014-00061.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308019 VERSAFITCUP DM ACETABULAR CUP 54 DOUBLE MOBILITY HC PE LINER LZO MEDACTA INTERNATIONAL SA 092015

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CODE 01.26.2854M - LOT. 092007| VERSAFITCUP DM PE ACETABULAR LINER 54/28 (K083116)