BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE REPLACEMENT

    MDR report key: 3872158 · Received June 12, 2014

    Report

    Report Number
    MW5036554
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    March 1, 2012
    Report Date
    June 12, 2014
    Manufacturer
    STRYKER
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2012 PT HAD KNEE REPLACEMENT SURGERY ON HIS LEFT KNEE. TWO MONTHS AFTER SURGERY HIS "KNEE FAILED". PT BEGAN HAVING SYMPTOMS OF SEVER KNEE PAIN, "STABBING" PAIN BEHIND HIS KNEE CAP, INABILITY TO GO UP/DOWN STAIRS, INABILITY TO EXTEND HIS KNEE BACKWARDS, AND HIS KNEE " LOCKING UP". PT SAYS HE HAS BEEN DISABLED EVER SINCE AND UNABLE TO WORK AS A MEAT CUTTER FOR GIANT FOODS. ALSO HE IS "ANGRY" THAT HE CAN'T GET HELP FROM FDA, NO ONE CALLS HIM BACK. HE WANTS THE "ARTICLE NUMBERS" FOR ANY RECALLED KNEE IMPLANTS FOR STRYKER. PT STATES THE KNEE IS FAULTY AND HE WANTS IT OUT OF HIS BODY. PT HAS AN APPOINTMENT (B)(6) 2014 WITH RHEUMATOLOGIST, AND ON (B)(6) 2014 WITH A NEW ORTHOPEDIC DOCTOR. HIS ORIGINAL DOCTOR NO LONGER TAKES HIS INSURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347423 KNEE REPLACEMENT KNEE REPLACEMENT JDI STRYKER

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention| S