BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_CORK_PRODUCT

    MDR report key: 3981682 · Received August 5, 2014

    Report

    Report Number
    0002249697-2014-02996
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN ACCOLADE SIZE 7 STEM. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALLEGED PERIPROSTHETIC FRACTURE INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. DEVICE HISTORY REVIEW RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT REPORTED. A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT REPORTED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT ACCOLADE HIP DUE TO PERIPROSTHETIC FRACTURE. DOCTOR REMOVED ACCOLADE STEM AND HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT ACCOLADE HIP DUE TO PERIPROSTHETIC FRACTURE. DOCTOR REMOVED ACCOLADE STEM AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456320 UNKNOWN_CORK_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R