BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIR HA PSL CUP/CLUSTR SHELL 70MM

    MDR report key: 1740196 · Received June 24, 2010

    Report

    Report Number
    2249697-2010-00729
    Event Type
    Injury
    Date Received
    June 24, 2010
    Date of Event
    May 28, 2010
    Report Date
    June 1, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K942900
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE ARTHROPLASTY WAS REVISED DUE TO INFECTION. THE ACETABULAR AND FEMORAL COMPONENTS WERE REVISED. THE COMPONENTS WERE IMPLANTED IN SITU FOR 10.31 Y. THE PATIENT PRESENTED WITH A (B) (6) SCORE OF 6 THREE MONTHS PRIOR TO REVISION SURGERY, AND A MAXIMUM SCORE OF 6 SINCE IMPLANTATION. (B) (4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECUR-FIR HA PSL CUP/CLUSTR SHELL 70MM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA 38876801

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R