BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRS CVD FEM ST W/O BODY 15X127

    MDR report key: 3887939 · Received June 23, 2014

    Report

    Report Number
    0002249697-2014-02401
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    PMA / PMN Number
    K040749
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A CEMENT FRACTURE INVOLVING AN MRS STEM WAS REPORTED. BASED ON THE LIMITED INFORMATION PROVIDED THERE IS NO INDICATION OR ALLEGATION THAT THE MRS STEM CONTRIBUTED TO THE REPORTED CEMENT FRACTURE. THE CEMENT PRODUCT WITHIN THIS PI WILL UNDERGO A PHASE 3 INVESTIGATION. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365625 MRS CVD FEM ST W/O BODY 15X127 IMPLANT KRO STRYKER ORTHOPAEDICS-MAHWAH TEC1111

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention