BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFIT HFX HIP STEM SIZE #07 127

    MDR report key: 1780812 · Received July 27, 2010

    Report

    Report Number
    2249697-2010-00915
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K031744
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 MFR. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFO BECOMES AVAILABLE; THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "STEM WAS LOOSE; DR REMOVED STEM AND CEMENT AND REPLACED WITH RESTORATION MOD CONE CONICAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIFIT HFX HIP STEM SIZE #07 127 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA 36877401

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other| R