BEUDAMED
    FDA Adverse Event Summary report: N

    UNKNOWN

    MDR report key: 3052507 · Received April 11, 2013

    Report

    Report Number
    1644408-2013-00210
    Date Received
    April 11, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS TO REMOVE THE PATIENT'S METAL-ON-METAL LINER PER THEIR REQUEST. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AND 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. NUMEROUS ATTEMPTS WERE MADE TO OBTAIN THE INFORMATION; HOWEVER THIS INFORMATION WAS NOT MADE AVAILABLE. THE ROOT CAUSE FOR THE REVISION WAS TO REMOVE THE METAL-ON-METAL LINER; NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    REVISION SURGERY - THE METAL-ON-METAL LINER WAS REMOVED PER THE PATIENT'S REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154588 UNKNOWN UNKNOWN KWA ENCORE MEDICAL, L.P. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention