BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMIC LEFT HIP

    MDR report key: 1070408 · Received June 30, 2008

    Report

    Report Number
    9616680-2008-00175
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    July 1, 2003
    Report Date
    June 5, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "PATIENT CALLED STRYKER TO REPORT THAT SHE IS EXPERIENCING A SQUEAK EMANATING FROM HER HIP. ALSO FEELING PAIN. MOSTLY WHEN SITTING FOR A WHILE, OR CROUCHING DOWN, OR BENDING DOWN. PAIN ONLY UPON MOVEMENT. GOES AWAY WHEN STARTS MOVING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CERAMIC LEFT HIP IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other