BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS TMZF HIP STEM #3

    MDR report key: 3070780 · Received April 22, 2013

    Report

    Report Number
    0002249697-2013-01349
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS A DUPLICATE OF PI ((B)(4)).THIS EVENT HAS BEEN REPORTED UNDER MFR REPORT FOR REPORT #(0002249697-2013-02078).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR REPORTED THE PATIENT'S METAL IONS WERE ELEVATED. CONCERN THAT IT IS FROM IMPLANTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR REPORTED THE PATIENT'S METAL IONS WERE ELEVATED. CONCERN THAT IT IS FROM IMPLANTS. THIS EVENT IS A DUPLICATE OF PI ((B)(4)).THIS EVENT HAS BEEN REPORTED UNDER MFR REPORT FOR REPORT #(0002249697-2013-02078).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172262 ACCOLADE PLUS TMZF HIP STEM #3 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 33961101

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other