BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN HIP

    MDR report key: 2851073 · Received November 19, 2012

    Report

    Report Number
    1644408-2012-00617
    Event Type
    Other
    Date Received
    November 19, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS DUE TO ARTHRITIS WITH AN UNDETERMINED DURATION IN-VIVO. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE NON-SERIOUS. 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 RECORDS AND PRODUCT COMPLAINT REPORT HISTORY COULD NOT BE PERFORMED WITHOUT INFORMATION REGARDING THE PART AND LOT NUMBERS. THE ROOT CAUSE FOR THE ARTHRITIS WAS NOT DETERMINED WITH CONFIDENCE. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY- THE PT HAS ARTHRITIS. THE SURGEON REVISED FROM A BIPOLAR HIP TO A TOTAL HIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention