BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE 132 SIZE 2.5

    MDR report key: 2071015 · Received April 20, 2011

    Report

    Report Number
    9616680-2011-00242
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAD HIP DYSPLASIA. BOTH HIPS REPLACED WITHIN 4 1/2 MONTHS OF EACH OTHER, FIRST LEFT THAN RIGHT. LEFT LEG FELT LIKE SHE WAS SITTING ON A KNOT/BALL BUT DIDN'T KNOW IT SHOULDN'T FEEL THAT WAY UNTIL SHE HAD THE RIGHT HIP DONE. SHE IS IN PAIN FROM THE HIP ALL THE WAY DOWN TO THE FOOT. ALSO HAS GROIN PAIN. PT LIMPS AND STILL USES A CANE. SHE IS ALSO TAKING MEDICATION FOR PAIN. HER RIGHT HIP REPLACEMENT DOES NOT HURT. TESTED FOR INFECTION, NO INFECTIONS FOUND BUT THERE IS INFLAMMATION. NERVE CONDUCTION STUDY WAS NEGATIVE. AN MRI WAS TAKEN ON HER BACK BUT THE PT HAS NOT RECEIVED RESULTS FROM THE DOCTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE 132 SIZE 2.5 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 29909903

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other