BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTAGE E1 INSERT DIA28 S56

    MDR report key: 5814136 · Received July 21, 2016

    Report

    Report Number
    3002806535-2016-00569
    Event Type
    Injury
    Date Received
    July 21, 2016
    Date of Event
    February 17, 2016
    Report Date
    June 21, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, ZIMMER BIOMET IN WARSAW, IN MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K101336 THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THESE TYPES OF EVENTS CAN OCCUR. UNDER NUMBER 8 ADVERSE REACTIONS, IT STATES, "AN UNSUITABLE CHOICE, INCORRECT POSITIONING, POOR ALIGNMENT OR INCORRECT FIXATION OF THE CUP MAY RESULT IN EXCESSIVE STRESSES ON THE INSERT, WHICH CAN REDUCE THE LIFE EXPECTANCY OF THE PROSTHESIS." PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    PATIENT WAS REVISED FOR DISLOCATION APPROXIMATELY 3 MONTHS POST-IMPLANTATION. MALPOSITIONED COMPONENTS AND PATIENT'S OBESITY WERE REPORTED AS CONTRIBUTING FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466884 AVANTAGE E1 INSERT DIA28 S56 PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 0000986080

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R