BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER 52MM

    MDR report key: 1938740 · Received December 21, 2010

    Report

    Report Number
    9616680-2010-00839
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    August 2, 2005
    Report Date
    December 3, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 BY THE PT THAT, "I HAD A TOTAL HIP REPLACEMENT ON MY RIGHT HIP ON (B)(6) 2005. SOON AFTER SURGERY I HAD A CHIRPING SOUND. MY DOCTOR ADVISED ME THAT THE IMPLANT WAS GETTING ITSELF WORN IN. THE LAST 6-8 MONTHS THE PAIN IN MY HIP HAD GOTTEN PROGRESSIVELY WORSE. I AM EXPERIENCING EXCRUCIATING PAIN WHEN WALKING, SITTING, AND EVEN NOW WHEN LAYING STILL. WEIGHT BEARING WHEN WALKING IS ALMOST IMPOSSIBLE. I HAVE SEVERE CLICKING AND POPPING WHEN WALKING AND SOMETIMES A LOUD SQUEAKING SOUND. WHEN BENDING DOWN OR GETTING UP, GOING UP AND DOWN STAIRS THAT CHIRPING SOUND IS GREATLY PRONOUNCED. I AM UNABLE TO WORK DUE TO THE PAIN. I AM AFRAID THAT I WILL EVENTUALLY BE DISABLED. I DO HAVE MY F/U APPT TOMORROW AFTERNOON AFTER HAVING BONE SCAN DONE. MY THOUGHT IS I NEED REVISION SURGERY, BUT I'LL WAIT AND SEE WHAT THE SURGEON SUGGESTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT HEMISPHERICAL CLUSTER 52MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 13760401

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other