BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFLEX-HA HIP STEM W/C TAPER

    MDR report key: 1810081 · Received August 16, 2010

    Report

    Report Number
    9616680-2010-00516
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K911585
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "REVISED DUE TO PERIPROSTHETIC FRACTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFLEX-HA HIP STEM W/C TAPER IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 66408601

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention