BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIHIP STEM

    MDR report key: 4951586 · Received July 28, 2015

    Report

    Report Number
    9614209-2015-00036
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    May 28, 2015
    Report Date
    July 27, 2015
    Manufacturer
    CORIN, LTD.
    Product Code
    LZO
    PMA / PMN Number
    K083312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DETAILS, PATIENT MEDICAL HISTORY, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MANUFACTURING RECORDS WILL BE REVIEWED. 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

    REVISION OF MINIHIP STEM AFTER 6 DAYS DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488335 MINIHIP STEM FEMORAL HIP STEM LZO CORIN, LTD. 580.0004 279878

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R