BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVOSOURCE BIOPIC BALL HEAD

    MDR report key: 21354666 · Received February 11, 2025

    Report

    Report Number
    MW5165896
    Event Type
    Injury
    Date Received
    February 11, 2025
    Date of Event
    July 1, 2021
    Report Date
    February 4, 2025
    Manufacturer
    NOVOSOURCE, LLC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HIP REPLACEMENT MY MEDICAL RECORDS HAVE NOVOHIP AS THE MATERIALS USED. IT WAS A FAILED REPLACEMENT, SO I HAD A REVISION DONE ON (B)(6) 2023 AND IT IS A FAILED HIP AS WELL. I WAS TOLD EXACTEC MADE NOVOHIP. I HAVE HAD NUMEROUS INJECTIONS, PHYSICAL THERAPY, CT, MRI, SEEN A NEUROLOGIST AS WELL AS GETTING A SECOND AND THIRD OPINION. NO ONE CAN HELP ME. THE PAIN IS TERRIBLE, AND I CANNOT EVEN LIFT MY LEG. I HAVE MISSED WORK; MANY MEDICAL BILLS AND MY GAIT IS NOT WHAT IT USED TO BE. DX LEFT HIP PAIN, DIFFICULTY WALKING, THE LUMBAR WAS CHECKED BECAUSE THEY THOUGHT MY PAIN MIGHT BE COMING FROM THE SPINE. REFERENCE REPORT #MW5165897.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042740 NOVOSOURCE BIOPIC BALL HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH NOVOSOURCE, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| S ADVIL| AMLODOPINE| DULCOLAX| DULOXETINE| HCTZ| MELOXICAM| METOPROLOL| ROSUVASTATIN| SYNTHROID