BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOVEMENT GREAT TOE PHALANX HEMI

    MDR report key: 2103645 · Received May 20, 2011

    Report

    Report Number
    1651501-2011-00044
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KWD
    PMA / PMN Number
    K092047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS ONGOING AND IS PENDING THE REVISION SURGERY. IF POSSIBLE, WE WILL ATTEMPT TO OBTAIN THE DEVICE IF IT IS REMOVED. IF ADDITIONAL INFO IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT A PT WAS IMPLANTED WITH A MOVEMENT GREAT TOE PHALANX HEMI ABOUT 2 MONTHS AGO. HE REPORTED THAT HE NEEDS TO REVISE THE IMPLANT DUE TO SWELLING AND AN INFECTION. HE THEN REPORTED THAT DURING SURGERY HE BELIEVED THAT THE IMPACTOR WAS INSUFFICIENT AND THAT THE LARGEST SIZE DEVICE WAS NOT BIG ENOUGH FOR THE PT. IT WAS ALSO NOTED THAT THE SURGEON REPORTED THAT HE HAD ISSUES GETTING EXPOSURE PRIOR TO IMPLANTING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOVEMENT GREAT TOE PHALANX HEMI TOE JOINT PHALANGEAL (HEMI-TOE) PROSTH. KWD ASCENSION ORTHOPEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R