BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3781367 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01587
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN MRH FEMUR. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IN PATIENT CONTROL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING A BROKEN STEM INVOLVING A MRH FEMUR WAS REPORTED. CONCLUSION: IT WAS REPORTED THERE WAS A REVISION OF THE LEFT HIP DUE TO FEMORAL STEM BROKEN. NO ALLEGATIONS WERE MADE REGARDING THE MRH FEMUR. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALES REP WAS MADE AWARE OF THE REVISION THAT OCCURRED (B)(6) 2014, THERE WAS AN MRH REVISION OF THE LEFT HIP DUE TO FEMORAL STEM BROKEN. ADDITIONAL EXPLANT: UNKNOWN STEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALES REP WAS MADE AWARE OF THE REVISION THAT OCCURRED (B)(6) 2014, THERE WAS AN MRH REVISION OF THE LEFT HIP DUE TO FEMORAL STEM BROKEN. ADDITIONAL EXPLANT: UNKNOWN STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259381 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention