BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3023689 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01084
    Event Type
    Death
    Date Received
    March 27, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PATIENT¿S DEATH INVOLVING AN UNKNOWN STRYKER HIP WAS REPORTED. 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

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN STRYKER HIP. THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH PATIENT'S COUNSEL THAT (B)(6)'S DEATH POTENTIALLY INVOLVES A STRYKER HIP REPLACEMENT. NO SPECIFIC PRODUCT INFORMATION OR ANY CLINICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH PATIENT'S COUNSEL THAT(B)(6)'S DEATH POTENTIALLY INVOLVES A STRYKER HIP REPLACEMENT. NO SPECIFIC PRODUCT INFORMATION OR ANY CLINICAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126366 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death