BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITY

    MDR report key: 5855984 · Received August 9, 2016

    Report

    Report Number
    9614209-2016-00118
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    April 25, 2016
    Report Date
    January 24, 2018
    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

    (B)(4). THIS MDR WAS ORIGINALLY FILED ON 01 JUL 2016 TO AN ESUBMISSIONS TEST ACCOUNT. ADDITIONAL INFORMATION HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THIS INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED. THE BROKEN UNITY PIN IS BEING RETURNED TO CORIN (B)(4) FOR EXAMINATION. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA. HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Additional Manufacturer Narrative · 1

    (B)(4) FINAL REPORT. THE RELEVANT DEVICE MANUFACTURING RECORD WAS IDENTIFIED AND REVIEWED. IT WAS FOUND THAT THIS DEVICE WAS MANUFACTURED IN 2014 AS PART OF A BATCH OF (B)(4) WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CORIN HAVE NOT RECEIVED ANY FURTHER FOLLOW UP REGARDING THIS EVENT AND NO COMPLICATIONS HAVE BEEN REPORTED. CORIN WILL CONTINUE TO MONITOR TRENDS RELATING TO THIS OR SIMILAR ISSUES WITH THIS DEVICE. CORIN NOW CONSIDERS THIS CASE CLOSED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A UNITY DRIVEN COLLARLESS PIN HAD BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A UNITY DRIVEN COLLARLESS PIN HAD BROKEN WHILST IN USE. THE SURGEON DECIDED TO LEAVE THE BROKEN PIN IN THE BONE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511486 UNITY TOTAL KNEE SYSTEM JWH CORIN MEDICAL 123.346.00 280698-10

    Patients

    Seq Age Sex Outcome Treatment
    1