BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMICAP TOE IMPLANT

    MDR report key: 5025408 · Received August 21, 2015

    Report

    Report Number
    3004154314-2015-00001
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    August 9, 2013
    Report Date
    July 31, 2015
    Manufacturer
    ARTHROSURFACE
    Product Code
    KWD
    PMA / PMN Number
    K031859
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 06/02/2016 UPDATE - THIS SUPPLEMENTAL MDR IS BEING FILED TO CORRECT THE DATE OF SURGERY (EVENT) AS (B)(6) 2013 PER THE RECORDS. IT WAS PREVIOUSLY REPORTED AS (B)(6) 2013. NO OTHER CHANGES.

    Description of Event or Problem · 1

    INITIAL SURGERY WAS IN (B)(6) 2013. PATIENT HAD CONTINUED PAIN. ON 10/06/2014 WAS LAST FOLLOW UP FOR ONGOING PAIN. SHE WAS TREATED FOR ORTHOTICS AND INJECTION. SHE INDICATED THAT SHE CONSULTED A SECOND SURGEON WHO RECOMMENDED AND REVISED HER TO A TOE FUSION. SHE NO LONGER HAS PAIN, BUT IS LESS ACTIVE. THE IMPLANTING SURGEON MENTIONED NO ISSUES WERE OBSERVED DURING THE INITIAL SURGERY. WE ARE UNAWARE AS TO THE CAUSE OF THE CONTINUED PAIN. THE PATIENT HAS SINCE HAD A TOE FUSION AND INDICATES NO FURTHER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555475 HEMICAP TOE IMPLANT HEMICAP TOE RESURFACING SYSTEM KWD ARTHROSURFACE 9M52-2545 75CC0605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other