BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION

    MDR report key: 10308873 · Received July 22, 2020

    Report

    Report Number
    1722511-2020-00016
    Event Type
    Injury
    Date Received
    July 22, 2020
    Date of Event
    August 30, 2019
    Report Date
    June 29, 2020
    Manufacturer
    ORTHO DEVELOPMENT
    Product Code
    LPH
    UDI-DI
    00822409010578
    PMA / PMN Number
    K131022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    IMMEDIATELY AFTER CLOSING THE WOUND FROM HIP REPLACEMENT SURGERY, AN X-RAY CONFIRMED A DISLOCATION. THE WOUND WAS REOPENED AND THE SURGEON MADE ADJUSTMENTS. DURING REDUCTION, A BONE FRACTURE OCCURRED NEAR THE TROCHANTER WHICH THE SURGEON WOUND WITH CABLE. THE SURGEON REPORTED THAT THIS WAS THE "RESULT OF VARIOUS CONDITIONS SUCH AS THE SOFT TISSUE CONDITION OF THE PATIENT, THE SHAPE OF THE ACETABULUM, THE BONE QUALITY, AND THE PIT HOLE IN THE OCM APPROACH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774255 OVATION TOTAL HIP PROSTHESIS LPH ORTHO DEVELOPMENT 100-0002 A183021 00822409010578

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR