BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITY

    MDR report key: 5846538 · Received August 4, 2016

    Report

    Report Number
    9614209-2015-00061
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Date of Event
    October 6, 2015
    Report Date
    August 9, 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

    (B)(4) FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING HOW THE DEVICE WAS BROKEN AND RETURN OF THE INSTRUMENT TO CORIN, WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION INTO THIS EVENT. HOWEVER, NOT ALL WERE RECEIVED, THEREFORE, THERE WAS ONLY LIMITED INFORMATION AVAILABLE FOR THIS INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE RETRIEVED AND REVIEWED, IT WAS FOUND THAT THE PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION WHEN MANUFACTURED IN 2013. THE INITIAL REPORTED AT CORIN GSA STATED THAT THEY HAD REVIEWED THE INSTRUMENT AND COULD FIND NO FAULT. UPON INVESTIGATION OF THE INSTRUMENT AT CORIN UK NO MARKINGS OR ANY OTHER CONCERNS WERE OBSERVED ON THE INSTRUMENT AND THERE WAS NO FAULT IN ITS FUNCTIONALITY. BASED ON THIS INFORMATION AND THE LACK OF INFORMATION PROVIDED CORIN NOW CONSIDERS THIS COMPLAINT CLOSED. HOWEVER, SHOULD ANY NEW INFORMATION COME TO LIGHT THIS CASE WILL 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 OF THE USA.

    Additional Manufacturer Narrative · 1

    (B)(4) FINAL REPORT. (B)(4). ADDITIONAL INFORMATION, INCLUDING HOW THE DEVICE WAS BROKEN AND RETURN OF THE INSTRUMENT TO CORIN, WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION INTO THIS EVENT. HOWEVER, NOT ALL WERE RECEIVED, THEREFORE, THERE WAS ONLY LIMITED INFORMATION AVAILABLE FOR THIS INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE RETRIEVED AND REVIEWED, IT WAS FOUND THAT THE PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION WHEN MANUFACTURED IN 2013. THE INITIAL REPORTED AT CORIN GSA STATED THAT THEY HAD REVIEWED THE INSTRUMENT AND COULD FIND NO FAULT. UPON INVESTIGATION OF THE INSTRUMENT AT CORIN UK NO MARKINGS OR ANY OTHER CONCERNS WERE OBSERVED ON THE INSTRUMENT AND THERE WAS NO FAULT IN ITS FUNCTIONALITY. BASED ON THIS INFORMATION AND THE LACK OF INFORMATION PROVIDED CORIN NOW CONSIDERS THIS COMPLAINT CLOSED. HOWEVER, SHOULD ANY NEW INFORMATION COME TO LIGHT THIS CASE WILL 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 OF THE USA.

    Additional Manufacturer Narrative · 1

    (B)(4) - INITIAL REPORT - ADDITIONAL INFORMATION, INCLUDING HOW THE DEVICE WAS BROKEN AND RETURN OF THE INSTRUMENT TO CORIN, HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE MANUFACTURING RECORDS ARE TO BE REVIEWED. THE INITIAL REPORTER AT CORIN GSA STATED THAT THEY HAVE REVIEWED THE INSTRUMENT AND COULD FIND NO FAULT. CORIN WILL INSPECT THE DEVICE UPON RECEIPT. 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

    A CUSTOMER COMPLAINED ABOUT A UNITY PS BOX CHISEL AND SAID IT WAS BROKEN, NO FURTHER DESCRIPTION WAS GIVEN.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED ABOUT A UNITY PS BOX CHISEL AND SAID IT WAS BROKEN, NO FURTHER DESCRIPTION WAS GIVEN.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINED ABOUT A UNITY PS BOX CHISEL AND SAID IT WAS BROKEN, NO FURTHER DESCRIPTION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498027 UNITY TOTAL KNEE SYSTEM JWH CORIN MEDICAL 123.043.40 065091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other