BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMN THR'D CUP SHELL ATC

    MDR report key: 313950 · Received January 26, 2001

    Report

    Report Number
    2243265-2001-00012
    Event Type
    Injury
    Date Received
    January 26, 2001
    Date of Event
    January 7, 2000
    Report Date
    December 27, 2000
    Manufacturer
    HOWMEDICA INC.
    Product Code
    MEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED REVISION SURGERY DUE TO LOOSENING OF THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3183 OMN THR'D CUP SHELL ATC IMPLANT MEH HOWMEDICA INC. NA C4196

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention