BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 2934638 · Received January 30, 2013

    Report

    Report Number
    0002249697-2013-00456
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 11, 2013
    Report Date
    May 8, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE AT THE TIME OF EVALUATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND/OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE DESCRIPTION WAS REPORTED AS TRIDENT ACETABULAR SYSTEM, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT, THAT ALLEGEDLY AFTER IMPLANTATION OF THE DEVICE, THE PATIENT BEGAN EXPERIENCING SIGNIFICANT PAIN AND DISCOMFORT IN THE AREA OF THE IMPLANTED DEVICE. IT IS FURTHER ALLEGED THAT THE PATIENT HAS UNDERGONE PREMATURE REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT, THAT ALLEGEDLY AFTER IMPLANTATION OF THE DEVICE, THE PATIENT BEGAN EXPERIENCING SIGNIFICANT PAIN AND DISCOMFORT IN THE AREA OF THE IMPLANTED DEVICE. IT IS FURTHER ALLEGED THAT THE PATIENT HAS UNDERGONE PREMATURE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40444 TRIDENT ALUMINA INSERT PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE MRA STRYKER ORTHOPAEDICS-MAHWAH 22993401

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| O| R