BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN STRYKER KNEE

    MDR report key: 7704014 · Received July 19, 2018

    Report

    Report Number
    0002249697-2018-02243
    Event Type
    Death
    Date Received
    July 19, 2018
    Date of Event
    December 7, 2015
    Report Date
    July 19, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SURVIVING SPOUSE, THROUGH THE FILING OF A LEGAL LAWSUIT, THAT THE PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY IN 2011 WHERE HE WAS IMPLANTED WITH A STRYKER KNEE SYSTEM. IT IS FURTHER ALLEGED THAT AFTER THE IMPLANTATION, THE PATIENT CONTACTED AN INFECTION THAT LASTED OVER THE SPAN OF FOUR YEARS AND WAS "NEVER BROUGHT UNDER CONTROL". THE PATIENT PASSED AWAY ON (B)(6) 2015

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545588 UNKNOWN STRYKER KNEE KNEE IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death