BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 3140908 · Received June 3, 2013

    Report

    Report Number
    0002249697-2013-01841
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    August 3, 2003
    Report Date
    May 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER DEVICE NOTED IN THIS REPORT WAS AN UNKNOWN ACCOLADE HIP. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. NOT RETURNED - LEGAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY SUBSEQUENT TO HER SURGERY, THE PATIENT EXPERIENCED PAIN AND CHRONIC DISLOCATIONS IN HER LEFT HIP. IT IS FURTHER ALLEGED THAT THE PATIENT UNDERWENT REVISION OF THE ACETABULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244890 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R