BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN 0 DEGREE ALUMINA INSERT

    MDR report key: 3002830 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00985
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 22, 2013
    Report Date
    May 11, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS. CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN TRIDENT ACETAULAR SYSTEM. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105753 UNKNOWN 0 DEGREE ALUMINA INSERT HIP IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| O| R