BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METAFIX

    MDR report key: 5849633 · Received August 5, 2016

    Report

    Report Number
    9614209-2016-00047
    Event Type
    Injury
    Date Received
    August 5, 2016
    Date of Event
    February 6, 2016
    Report Date
    August 5, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    LZO
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP REPORT IN ERROR. ADDITIONAL INFORMATION, INCLUDING POST PRIMARY AND PRE REVISION X-RAYS AND THE EXPLANT WERE REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER THEY WERE NOT AVAILABLE, THEREFORE, THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WERE IDENTIFIED AND REVIEWED, IT WAS FOUND THAT THE PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION WHEN MANUFACTURED. THE INITIAL REPORTER TO CORIN UK CONFIRMED THAT DURING SURGERY THE PATIENT'S ANTERIOR CALCAR WAS FRACTURED AND CERCLAGE WIRE WAS THIS PLACED AROUND THE FEMUR. CORIN HAVE CONCLUDED THAT THE FRACTURE MAY HAVE BEEN A CONTRIBUTORY CAUSE OF THE SUBSIDENCE OF THE STEM; HOWEVER, THIS CANNOT BE PROVEN WITH THE INFORMATION PROVIDED. 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 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

    METAFIX REVISION SEVERAL WEEKS AFTER SURGERY DUE TO THE IMPLANT SUBSIDING. THE INITIAL REPORTER TO CORIN HAS STATED THAT DURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504345 METAFIX HIP STEM LZO CORIN MEDICAL 579.2004 318385

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R