BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT

    MDR report key: 6955441 · Received October 17, 2017

    Report

    Report Number
    3004154314-2017-00022
    Event Type
    Injury
    Date Received
    October 17, 2017
    Report Date
    September 18, 2017
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    KWD
    PMA / PMN Number
    K031859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE REPORTED PAIN CANNOT BE ASCERTAINED WITH THE INFORMATION AVAILABLE. HOWEVER, ACCORDING TO PATIENT'S TREATING SURGEON, SHE DEVELOPED AN OSTEOPHYTE AROUND THE IMPLANT WHICH MAY BE A CONTRIBUTOR TO THE REPORTED PAIN. AS NO IMPLANT SPECIFIC INFORMATION WAS PROVIDED, REVIEW OF MANUFACTURING OR PERFORMANCE HISTORY OF THE SUBJECT IMPLANT LOT CANNOT BE PERFORMED. THE PATIENT WAS ADVISED TO CONSULT HER ORIGINAL PHYSICIAN WHO IMPLANTED HEMICAP TO DISCUSS HER CURRENT ISSUES AND ASSESS HER TOE. NO FURTHER INFORMATION WAS RECEIVED BY ARTHROSURFACE TO DATE FROM THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT REACHED OUT TO ARTHROSURFACE VIA WEBSITE TO REPORT PAIN IN HER TOE. THERE WAS NO PAIN RELIEF SINCE THE TOE JOINT REPLACEMENT SHE HAD 7 YEARS AGO. UPON RECENT VISIT TO A SURGEON, SHE WAS TOLD THAT SHE NEEDS A REVISION AS THERE IS A BONY GROWTH AROUND THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736415 CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT TOE JOINT, PHALANGEAL (HEMI-TOE) PROSTHESIS KWD ARTHROSURFACE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other