BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN

    MDR report key: 2845067 · Received November 9, 2012

    Report

    Report Number
    1644408-2012-00590
    Event Type
    Other
    Date Received
    November 9, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS NOT REPORTED. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT COMPLAINT REPORT HISTORY COULD NOT BE CONDUCTED WITHOUT INFORMATION REGARDING THE PART AND LOT NUMBERS. THE ROOT CAUSE WAS MOST LIKELY DUE TO THE REVISION OF ANOTHER MANUFACTURER'S DEVICE (MAKO SURGICAL).

    Description of Event or Problem · 1

    REVISION SURGERY- THE DJO HEAD WAS REMOVED, DUE TO COMPETITOR'S CUP AND LINER NEED TO BE REVISED. THE SALES REPRESENTATIVE INTENDS TO FOLLOW UP WITH THE SURGEON TO OBTAIN ORIGINAL SURGERY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN JWH ENCORE MEDICAL, L.P. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention