BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITY

    MDR report key: 5855998 · Received August 9, 2016

    Report

    Report Number
    9614209-2016-00129
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Report Date
    August 18, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    JWH
    PMA / PMN Number
    K113060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. PLEASE NOTE: THIS MDR WAS ORIGINALLY FILED ON 22 JUL 2016 TO AN ESUBMISSIONS TEST ACCOUNT. NO AE REPORTED, AN ALTERNATIVE DEVICE WAS USED. ADDITIONAL INFORMATION AND THE RETURN OF THE DEVICE WAS REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION, AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4) FINAL REPORT. NO ADVERSE EVENT REPORTED, AN ALTERNATIVE DEVICE WAS USED. ADDITIONAL INFORMATION, INCLUDING THE DEVICE LOT CODE AND RETURN OF THE DEVICE WERE REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION, HOWEVER, THESE WERE NOT PROVIDED. THEREFORE, THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THIS INVESTIGATION. THE DEVICE LOT CODE WAS NOT PROVIDED AND THUS THE DEVICE MANUFACTURING RECORDS COULD NOT BE IDENTIFIED OR REVIEWED. THE REPORTED DEVICE IN THIS CASE WAS NOT RETURNED TO CORIN (B)(4) FOR EXAMINATION, SO AT THIS TIME A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THIS, CORIN NOW CONSIDERS THIS CASE CLOSED, HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED, THIS CASE MAY BE REOPENED 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    UNITY KEEL PUNCH CONNECTOR WOULD NOT LOCK ONTO KEEL PUNCH DURING SURGERY.

    Description of Event or Problem · 1

    UNITY KEEL PUNCH CONNECTOR WOULD NOT LOCK ONTO KEEL PUNCH DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514730 UNITY TOTAL KNEE SYSTEM JWH CORIN MEDICAL 123.063.00 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other