BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMN THR'D CUP SHELL ATC

    MDR report key: 485250 · Received September 24, 2003

    Report

    Report Number
    2243265-2003-00088
    Event Type
    Injury
    Date Received
    September 24, 2003
    Date of Event
    June 8, 2002
    Report Date
    September 5, 2003
    Manufacturer
    HOWMEDICA OSTEONICS CORP.
    Product Code
    MEH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS WEAR OF THE PE INSERT WITH SUBSEQUENT LOOSENING OF THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMN THR'D CUP SHELL ATC IMPLANT MEH HOWMEDICA OSTEONICS CORP. NA CL37

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention