BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN - LEFT TOTAL TITANIUM STRYKER HIP REPLACEMEN

    MDR report key: 2221277 · Received August 17, 2011

    Report

    Report Number
    2249697-2011-01197
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    April 23, 2011
    Report Date
    July 25, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "APPROXIMATELY 2 MONTHS AFTER THE LEFT HIP REPLACEMENT WAS PUT IN HE WAS GETTING UP OFF OF THE COUCH AND HEARD A SNAP OR POPPING NOISE WHICH RESULTED IN IMMEDIATE EXTREME PAIN. HE HAS EXTREME PAIN EVER SINCE. HE IS STILL USING A WHEEL CHAIR AND A WALKER TO GET AROUND. HE IS IN EXTREME PAIN AND ALL ACTIVITIES ARE HINDERED. HE CANNOT SLEEP. IT FEELS LIKE SHARDS OF GLASS POKING THROUGH HIS SKIN WHERE THE REPLACEMENT WAS PUT IN. THE DOCTOR STATES THAT HE NEEDS TO GET HIS SCIATIC NERVE LOOKED INTO. X-RAYS HAVE BEEN TAKEN AND THE DOCTOR STATES THAT THE IMPLANT IS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN - LEFT TOTAL TITANIUM STRYKER HIP REPLACEMEN IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other