BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM +4 LFIT V40 HEAD

    MDR report key: 2933300 · Received January 29, 2013

    Report

    Report Number
    0002249697-2013-00404
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K010757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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. HOSPITAL WILL NOT RELEASE MEDICAL REPORTS, X-RAYS, DEVICES, OP NOTES. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH DISLOCATED CONSTRAINED LEFT HIP. SURGEON REPLACED THE LINER (BIOMET), REPLACED PROXIMAL FEMORAL COMPONENT, HEAD AND 70MM BODY SEGMENT. EVEN THOUGH PATIENTS' FOURTH REVISION THE EXPLANTS ARE FROM THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38448 32MM +4 LFIT V40 HEAD IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention