BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON UNIVERSAL B/P NON-BEADED

    MDR report key: 1192791 · Received October 8, 2008

    Report

    Report Number
    2249697-2008-00299
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    June 1, 2004
    Report Date
    September 9, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K915512
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVAL. NO EVAL WILL BE PERFORMED. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTER VIA A MAUDE THAT, "REPORTER STATES THAT SHE IS ALLERGIC TO NICKEL AND WAS TOLD THAT THERE WAS NO NICKEL IN THE IMPLANT. AFTER SURGERY, REPORTER STATES THAT SHE HAD HIVES, INCREASED HEART RATE, TROUBLE BREATHING AND ITCHING WHEN PT WAS DISCHARGED FROM THE HOSPITAL, SHE STATES THAT SHE DEVELOPED A RASH AROUND THE INCISION SITE. AFTER STAPLES WERE REMOVED 3 MONTHS LATER, PT DEVELOPED OPEN SORES AND A RASH AROUND THE INCISION THAT SPREAD TO THE OTHER SIDE OF HER BODY. PT WENT TO HER DOCTOR AND CONTACTED HOWMEDICA AND WAS TOLD THAT THERE WAS NO NICKEL IN THE IMPLANT. PT WAS SEEN BY A DERMATOLOGIST AND REQUESTED A SAMPLE OF THE IMPLANT. THE SAMPLE THAT WAS SENT WAS TITANIUM AND ALLOYED. THE DERMATOLOGIST TAPED THE SAMPLE TO HER ARM, AND IT CAUSED A RED CIRCLE. PT STATES THAT SHE DID RESEARCH AND REQUESTED A BLOOD TEST FOR NICKEL, TEST RESULTS CAME BACK STATING THAT SHE WAS ALLERGIC TO NICKEL. PT DID MORE RESEARCH, AND FOUND THAT THE IMPLANT WAS MADE OF COBALT AND ALLOYED." PT STATES THAT SHE INFORMED HER DOCTOR AND HE REFERRED TO AN ORTHOPEDICS DOCTOR. PT STATES THAT SHE WAS TOLD BY THE ORTHOPEDIST THAT THE BONE PLATE COULD NOT BE REMOVED DUE TO THE FACT SHE COULD LOSE HER LEG. PT STATES THAT THE ORTHOPEDIST SAID THAT THE IMPLANT DID CONTAIN NICKEL. PT HAD REVISION SURGERY, HOWEVER, SHE IS NOW DISABLED AND SHE HAS TO USE A CANE TO WALK AND SHE FALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURACON UNIVERSAL B/P NON-BEADED IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention