BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOHIP TOTAL HIP SYSTEM

    MDR report key: 18699552 · Received February 13, 2024

    Report

    Report Number
    3014273644-2024-00001
    Event Type
    Injury
    Date Received
    February 13, 2024
    Date of Event
    January 19, 2024
    Report Date
    February 13, 2024
    Manufacturer
    NOVOSOURCE, LLC
    Product Code
    LPH
    PMA / PMN Number
    K132158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOSOURCE WILL NOT TAKE ANY REMEDIAL ACTION AS NO INHERIT DEFICIENCY IN THE NOVOHIP SYSTEM WAS IDENTIFIED. ALL CATALOG IMPLANTS FUNCTIONED AS INTENDED AND DO NOT INTRODUCE ANY UNACCOUNTED RISK TO THE PATIENT. USE AND SELECTION OF NOVOSOURCE IMPLANT COMPONENTS ARE AT THE JUDGMENT OF THE SURGEON REGARDING THE PATIENTS ANATOMY, THEREFORE NO USER ERROR HAS BEEN IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT'S PROXIMAL FEMUR FRACTURED DURING A TOTAL HIP ARTHOPLASTY. AFTER FOLLOWING UP WITH THE REPORTER, IT WAS DISCOVERED THAT THE OPERATION WAS A TRAUMA CASE, MEANING NO PRE-OPERATIVE PLANNING OCCURRED. DURING THE SURGERY, THE SURGEON DETERMINED THAT THE DESIRED LEG LENGTH WAS NOT MET WITH THE INITIAL SELECTION OF A SIZE 9 STEM. AS A RESULT, THE SURGEON ELECTED TO BROACH TO A GREATER SIZE STEM. A SIZE 11 NOVOHIP STEM (PN: 1125-0011, LN: EUR0034) WAS SELECTED AND A PROXIMAL FEMUR FRACTURE OCCURRED. THE SURGEON REPAIRED THE PATIENT'S FEMUR UTILIZING CABLES AND IMPLANTS FROM ANOTHER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59530 NOVOHIP TOTAL HIP SYSTEM HIP PROSTHESIS LPH NOVOSOURCE, LLC 1125-0011 EUR0034

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other| R