BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2981396 · Received February 27, 2013

    Report

    Report Number
    0002249697-2013-00796
    Event Type
    Death
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE RESEARCHER AT THE HOSPITAL REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2012 WITH SHORTNESS OF BREATH AND LATER DIED. THE RESEARCHER REPORTED THAT THE DIAGNOSIS IS DOCUMENTED AS CARDIAC ARREST. NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS STAGE.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION HAS BEEN RECEIVED. THE CLINICAL RESEARCHER IS CURRENTLY PREPARING A REPORT THAT WILL DETAIL THE PRODUCT CODES AND FINDINGS. ONCE AVAILABLE, IT WILL BE SUBMITTED IN THE SUPPLEMENTAL REPORT. CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN TRIATHLON KNEE. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CLINICAL RESEARCHER REPORTED THAT A PATIENT WHO WAS A SUBJECT IN THE TRIATHLON OUTCOMES STUDY HAS DIED.

    Description of Event or Problem · 1

    THE CLINICAL RESEARCHER REPORTED THAT A PATIENT WHO WAS A SUBJECT IN THE (B)(4) STUDY HAS DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85059 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MRA STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death