BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT

    MDR report key: 8485160 · Received April 4, 2019

    Report

    Report Number
    3004154314-2019-00001
    Event Type
    Injury
    Date Received
    April 4, 2019
    Report Date
    March 8, 2019
    Manufacturer
    ARTHROSURFACE, INC.
    Product Code
    KWD
    PMA / PMN Number
    K031859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED INDICATING THE DEVICES WERE MANUFACTURED, INSPECTED AND PACKAGED TO SPECIFICATION. SINCE THE PATIENT STARTED TO FEEL PAIN 3 YEARS AFTER SURGERY, IT IS POSSIBLE THAT THE ARTHRITIS MAY HAVE PROGRESSED TO THE OTHER SIDE OF THE JOINT. NO OTHER COMPLAINTS OR REPORTS CONCERNING PAIN OR OTHER ADVERSE EVENTS WERE REPORTED FOR THE PART LOTS IN QUESTION. AS REQUESTED BY THE PATIENT, LOCAL SURGEON INFORMATION WAS PROVIDED FOR OBTAINING A SECONDARY OPINION. THE FOLLOWING IS THE LOT INFO OF IMPLANT COMPONENTS RECEIVED BY THE PATIENT. PN: 9095-0018-W LOT: 75EK0313 MFG. DATE: 05/2011 EXP. DATE: 05/2016; PN: 9M52-2535-W LOT: 75DK0534 MFG. DATE: 04/2011 EXP. DATE: 04/2016. ANY FURTHER INFORMATION RECEIVED FROM THE PATIENT WILL BE DOCUMENTED IN THE COMPLAINT FILE AND REVIEWED FOR REPORTING THROUGH A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    PATIENT RECEIVED A TOE DF IMPLANT IN (B)(6) 2011 AND STARTED TO FEEL PAIN AFTER 3 YEARS OF IMPLANTATION. ON CONSULTING A NEW PODIATRIST, SHE WAS TOLD HER ONLY OPTION IS TO FUSE THE MTP JOINT. THE PATIENT IS CURRENTLY EXPERIENCING EXCRUCIATING PAIN AND WANTS TO KNOW IF IMPLANTATION OF A PHALANGEAL COMPONENT WOULD HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274649 CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT MTP HEMI-TOE PROSTHESIS KWD ARTHROSURFACE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other