BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ACCOLADE 1 STEM IMPLANT DATE 12/FEB/2015 APPROX.

    MDR report key: 7798673 · Received August 20, 2018

    Report

    Report Number
    0002249697-2018-02601
    Event Type
    Injury
    Date Received
    August 20, 2018
    Date of Event
    July 23, 2018
    Report Date
    August 20, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED BY REP: "[SURGEON] REMOVED AN ACCOLADE 1 STEM [IMPLANTED APPROXIMATELY (B)(6) 2015] DUE TO THE ORIGINAL SURGEON LEAVING THE PATIENT TOO LONG. WE REVISED IT WITH A RESTORATION MODULAR STEM". ALSO, A 28 -4 METAL HEAD WAS REVISED TO A 28 +4 METAL HEAD, AND A POLY ADM/MDM INSERT WAS REVISED FOR THE SAME CATALOG NUMBER (METAL LINER NOT REVISED). HEAD AND INSERT WERE IMPLANTED (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640450 UNKNOWN ACCOLADE 1 STEM IMPLANT DATE 12/FEB/2015 APPROX. HIP IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R