BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIHIP

    MDR report key: 5852861 · Received August 8, 2016

    Report

    Report Number
    9614209-2016-00078
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    April 23, 2015
    Report Date
    August 8, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    LZO
    PMA / PMN Number
    K083312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    C-1404 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 A RESULT OF A RETROSPECTIVE REVIEW. ADDITIONAL INFORMATION, INCLUDING DEVICE DETAILS AND THE RETURN OF THE REPORTED DEVICES WERE REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, THESE WERE NOT PROVIDED, THEREFORE THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. NEITHER THE DEVICE DETAILS OR DEVICES WERE PROVIDED TO CORIN UK, THUS, THE DEVICE MANUFACTURING RECORDS COULD NOT BE RETRIEVED AND REVIEWED, NOR COULD THE FAILURE MODE BE VERIFIED OR A ROOT CAUSE IDENTIFIED. 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 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 MALE MINIHIP SET HAD A LOOSE CONNECTION BETWEEN THE TRIAL NECKS AND RASPS WHICH WAS CAUSING THE TWO COMPONENTS TO DISCONNECT. THIS RESULTED IN ONE OF THE NECK TRIALS DROPPING OFF THE RASP ONTO THE FLOOR DURING TRIAL REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507709 MINIHIP CORIN MINIHIP STEM LZO CORIN MEDICAL 580.9600 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown