BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITY

    MDR report key: 5852913 · Received August 8, 2016

    Report

    Report Number
    9614209-2016-00040
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    June 1, 2015
    Report Date
    August 8, 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

    C-1451 INITIAL REPORT. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP REPORT IN ERROR. THIS CASE WAS SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW. ADDITIONAL INFORMATION WAS REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, NOT ALL WAS PROVIDED, THEREFORE THERE WAS ONLY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THE DEVICE DETAILS WERE NOT PROVIDED TO CORIN, THUS, THE DEVICE MANUFACTURING RECORDS COULD NOT BE IDENTIFIED OR REVIEWED. THE INSTRUMENT SET WAS RETURNED TO CORIN UK AND EXAMINED, THE REPORTED FAILURE MODE WAS VERIFIED. THE ROOT CAUSE IDENTIFIES THAT THE RUSTING EFFECT COULD BE DUE TO THE PASSIVATION PROCESS, CONSEQUENTLY THE CLEANING/PASSIVATION PROCESS WILL BE UPDATED. BASED ON THIS, CORIN NOW CONSIDERS THIS CASE CLOSED. 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.

    Description of Event or Problem · 1

    A STC UNITY INSTRUMENT KIT WAS RETURNED AS THERE WAS EVIDENCE OF RUST/CORROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507705 UNITY TOTAL KNEE SYSTEM JWH CORIN MEDICAL NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown