BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN HIP

    MDR report key: 2931666 · Received January 24, 2013

    Report

    Report Number
    1644408-2013-00028
    Event Type
    Other
    Date Received
    January 24, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWY
    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 TO REMEDY A DISLOCATION AFTER AN UNDETERMINED TIME OF PATIENT USE. THE OUTCOMES ATTRIBUTED TO THIS EVENT ARE HOSPITALIZATION - INITIAL OR PROLONGED AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT. THE HEALTHCARE PROFESSIONAL INDICATED A SIGNIFICANT ADVERSE EVENT TO THE PATIENT. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REVISION SURGERY. 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 OF THE REVISION SURGERY WAS NOT DETERMINED WITH CONFIDENCE. 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 DISLOCATED. THE SURGEON REMOVED THE CUP, LINER, AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33783 UNKNOWN HIP UNK KWY ENCORE MEDICAL, L.P. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention