BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3924347 · Received July 9, 2014

    Report

    Report Number
    0002249697-2014-02594
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 12, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN CEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CEMENT CRACK/FRACTURE INVOLVING AN UNKNOWN CEMENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS DEVICE DETAILS AND RETURN, OPERATIVE REPORTS, PATHOLOGY REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 YEARS AFTER PRIMARY OPERATION REVISION OF GMRS REQUIRED AS CEMENT MANTLE FRACTURED IN FEMUR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS THE CEMENT SURROUNDING THE STEM WHICH FRACTURED HENCE REVISION SURGERY REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400816 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention