BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT M-HA HIP STEM

    MDR report key: 550736 · Received October 19, 2004

    Report

    Report Number
    9616680-2004-00061
    Event Type
    Injury
    Date Received
    October 19, 2004
    Date of Event
    September 21, 2004
    Report Date
    September 27, 2004
    Manufacturer
    STRYKER ORTHOPAEDICS, CORK
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    LOOSENING OF IMPLANT HAD BEEN REPORTED. IT WAS ALSO REPORTED THAT THERE WAS VERY MINIMAL BONE INGROWTH. PT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT M-HA HIP STEM IMPLANT KWY STRYKER ORTHOPAEDICS, CORK NA 27717901

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention