BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPRO IMPLANT RIGHT HALLUX AND LONG ARM AUSTIN WITH INTERNAL FIXATION RIGHT FOO

    MDR report key: 8124666 · Received November 30, 2018

    Report

    Report Number
    MW5081760
    Event Type
    Injury
    Date Received
    November 30, 2018
    Date of Event
    October 9, 2015
    Report Date
    November 29, 2018
    Manufacturer
    BIOPRO, INC.
    Product Code
    KWD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD JOINT REPLACEMENT SURGERY ON MY RIGHT FOOT BIG TOE. JOINT WAS REMOVED AND THE PROCEDURE PERFORMED WAS A KELLER ARTHROPLASTY WITH BIOPRO IMPLANT RIGHT HALLUX WITH LONG ARM AUSTIN WITH INTERNAL FIXATION RIGHT FOOT. AFTER SURGERY HEALING DID NOT PROGRESS AS EXPECTED. MY CONDITIONED WORSENED WITH CONTINUOUS SWELLING. PHYSICAL THERAPY AND STEROIDS WERE TEMPORARILY HELPFUL. I HAD TO WEAR A SHOE THAT WAS A SIZE AND A HALF LARGER THAN MY LEFT BECAUSE OF CONTINUED SWELLING AND PAIN. AFTER A YEAR WITH NO RELIEF OR IMPROVEMENT I HAD TO HAVE SURGERY TO REMOVE THE IMPLANT IN (B)(6) 2016. THE FINDINGS OF THE SECOND SURGERY WERE LOOSE HARDWARE. THE MANUFACTURER OF THE DEVICES USED WERE PARAGON FOR THE SCREWS 3.0 X 16MM AND 3.0X14MM CANNULATED SCREWS AND BIOPRO IMPLANT SERIAL #(B)(4) LOT #116620. I WOULD LIKE TO KNOW IF THERE ARE ANY OTHER COMPLAINTS OF FAILURE OR RECALLS ON THIS DEVICE. I AM STILL HAVING ISSUES EVEN AFTER REMOVAL AND MAY HAVE TO HAVE A 3RD SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958198 BIOPRO IMPLANT RIGHT HALLUX AND LONG ARM AUSTIN WITH INTERNAL FIXATION RIGHT FOO PROTHESIS, TOE, HEMI-PHALANGEAL KWD BIOPRO, INC. 116620

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention