BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUREFIT STEM

    MDR report key: 1150460 · Received September 5, 2008

    Report

    Report Number
    2249697-2008-00252
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWY
    PMA / PMN Number
    UNK
    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. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IMPLANTED BY DR. APPROX. 6 WEEKS AGO. PT HIP INFECTED. NEEDED TO BE REVISED. REMOVED ALL IMPLANTS AND REVISED USING CEMENT SPACERS, ANTIBIOTIC, AND WILL REVISE WHEN INFECTION IS GONE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECUREFIT STEM IMPLANT KWY STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention