BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORIN BIPOLAR

    MDR report key: 3772321 · Received March 17, 2014

    Report

    Report Number
    9614209-2014-00012
    Event Type
    Other
    Date Received
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    CORIN LTD.
    Product Code
    KWY
    PMA / PMN Number
    K925897
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. DEVICE DETAILS, DEVICE, PT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION WILL BE REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. PLEASE NOTE: THIS REPORT FILED WITH THE FDA IS 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

    IN A SURGERY CARRIED OUT IN (B)(6) 2014 (THE EXACT DATE OF SURGERY HAS NOT BEEN PROVIDED) THE INNER MODULAR HEAD CAME OUT OF THE OUTER PLASTIC SHELL OF A BIPOLAR IMPLANT DURING REDUCTION TESTING WHILST SIMULATING EXTERNAL ROTATION. THE THEATRE STAFF WERE UNSUCCESSFUL IN RETURNING THE INNER MODULAR HEAD TO THE OUTER SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157180 CORIN BIPOLAR FEMORAL HEAD BIPOLAR COMPONENT KWY CORIN LTD. E011.543 240478

    Patients

    Seq Age Sex Outcome Treatment
    1 DATA FOR ASSOCIATED FEMORAL STEM HAS NOT BEEN| PROVIDED TO CORIN.