BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITY

    MDR report key: 5849460 · Received August 5, 2016

    Report

    Report Number
    9614209-2016-00036
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Report Date
    August 8, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    JWH
    PMA / PMN Number
    K113060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    C-1362 INITIAL REPORT. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP IN ERROR. THIS CASE WAS SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW. ADDITIONAL INFORMATION AND DEVICE DETAILS WERE REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, THESE WERE NOT PROVIDED, THEREFORE THERE WAS ONLY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION AND THE DEVICE MANUFACTURING RECORDS COULD NOT BE IDENTIFIED OR REVIEWED. THE MANUFACTURING PROCESS FOR THESE INSTRUMENTS IS CURRENTLY BEING UPDATED. BASED ON THIS, CORIN NOW CONSIDERS THIS CASE CLOSED, HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE THE USA.

    Description of Event or Problem · 1

    AN STC UNITY INSTRUMENT SET WAS SENT BACK FROM A HOSPITAL AS THE DEVICES APPEARED TO HAVE RUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504486 UNITY TOTAL KNEE SYSTEM JWH CORIN MEDICAL 123.306.00 065092

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown