BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3070745 · Received April 22, 2013

    Report

    Report Number
    0002249697-2013-01352
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    August 9, 2005
    Report Date
    March 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN, SWELLING, AND/OR LACK OF MOBILITY INVOLVING A TRIDENT HIP REPLACEMENT SYSTEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN TRIDENT HIP REPLACEMENT SYSTEM. THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT THE PATIENT UNDERWENT A STRYKER TRIDENT HIP REPLACEMENT SURGERY OF HIS RIGHT HIP ON OR ABOUT (B)(6) 2005. IT IS ALLEGED THAT THE PATIENT HAD CONSTANT PAIN, SWELLING, AND /OR LACK OF MOBILITY AND WAS REVISED ON (B)(6) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT THE PATIENT UNDERWENT A STRYKER TRIDENT HIP REPLACEMENT SURGERY OF HIS RIGHT HIP ON OR ABOUT (B)(6) 2005. IT IS ALLEGED THAT THE PATIENT HAD CONSTANT PAIN, SWELLING, AND /OR LACK OF MOBILITY AND WAS REVISED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172008 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention