BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMUS FLEXIBLE GREAT TOE WITH GROMMETS IMPLANT (FGT)

    MDR report key: 5085203 · Received September 17, 2015

    Report

    Report Number
    3004983210-2015-00038
    Event Type
    Injury
    Date Received
    September 17, 2015
    Date of Event
    August 24, 2014
    Report Date
    September 16, 2015
    Manufacturer
    TORNIER, INC.
    Product Code
    KWH
    PMA / PMN Number
    K981194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    ON OR ABOUT (B)(6) 2007 (B)(6) (THE PATIENT) PRESENTED TO (B)(6) CENTERS AND DR. (B)(6) FOR TREATMENT AND EVALUATION OF HER RIGHT FOOT PAIN. SOMETIME PRIOR TO (B)(6) 2011 (B)(6) DEVELOPED OSTEOARTHRITIS IN HER RIGHT FOOT. ON OR ABOUT (B)(6) 2011 DR. (B)(6) RECOMMENDED THAT (B)(6) UNDERGO AN AUSTIN BUNIONECTOMY WITH POSSIBLE FIRST METATARSAL PHALANGEAL JOINT IMPLANT - RIGHT FOOT USING THE PRODUCT. ON OR ABOUT (B)(6) 2011 (B)(6) WAS ADMITTED TO (B)(6) FOR PERFORMANCE OF THE SURGICAL PROCEDURE BY DR. (B)(6). ON OR ABOUT (B)(6) 2011 DR. (B)(6) PERFORMED THE SURGICAL PROCEDURE ON (B)(6) AT (B)(6) AND IMPLANTED THE FGT IMPLANT INTO (B)(6) RIGHT FOOT. ON OR ABOUT (B)(6) 2013 JANET PRESENTED TO (B)(6) CENTERS AND DR. (B)(6) FOR POST-OPERATIVE FOLLOW UP CARE OF HER RIGHT FOOT AND COMPLAINED OF RIGHT FOOT PAIN AT THE TOP OF HER FIRST METATARSAL PHALANGEAL JOINT SINCE (B)(6) 2013. AT THIS TIME DR. (B)(6) CONDUCTED A PHYSICAL EXAMINATION OF (B)(6) RIGHT FOOT, ORDERED AND REVIEWED X-RAYS OF (B)(6) RIGHT FOOT AND INTERPRETED SAID X-RAYS AS INDICATING A POSSIBLE FRACTURE OF THE BONE IN (B)(6) RIGHT FOOT AROUND THE PRODUCT. ON OR ABOUT (B)(6) 2013 (B)(6) PRESENTED TO THE OFFICES OF (B)(6) CENTERS AND DR. (B)(6) FOR POST OPERATIVE FOLLOW UP CARE WITH CONTINUING COMPLAINTS OF RIGHT FOOT PLAIN, SHE WAS SEEN AND EXAMINED BY DR. (B)(6) AND DR. (B)(6) RECOMMENDED THAT (B)(6) UNDERGO A BONY RESECTION AROUND THE PRODUCT WITH POSSIBLE REPLACEMENT OF THE PRODUCT (A SECOND SURGICAL PROCEDURE). ON OR ABOUT (B)(6) 2013 (B)(6) WAS ADMITTED TO (B)(6) FOR THE PERFORMANCE OF A SECOND SURGERY BY DR. (B)(6). ON (B)(6) 2013 DR. (B)(6) PERFORMED THE SECOND SURGERY ON (B)(6) AND REMOVED THE PRODUCT AND REPLACED IT WITH ANOTHER FUTURA PRIMUS FLEXIBLE GREAT TOE IMPLANT (THIS INCIDENT HAS ALREADY BEEN REPORTED TO THE FDA UNDER MDR NUMBER 3004983210-2013-00021) ON (B)(6) 2014 (B)(6) PRESENTED TO (B)(6) COMPLAINING OF RIGHT FOOT PAIN. ON OR ABOUT (B)(6) 2014 DR. (B)(6) SURGICALLY REMOVED THE PRODUCT AND PERFORMED A FUSION OF (B)(6) FIRST MATATARSALPHALANGEAL JOINT WITH PLATES AND SCREWS (A THIRD SURGERY, AND THE SECOND TIME (B)(6) HAD THE ORIGINAL SURGERY REVISED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615351 PRIMUS FLEXIBLE GREAT TOE WITH GROMMETS IMPLANT (FGT) TOE PROSTHESIS KWH TORNIER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other