BEUDAMED
    FDA Adverse Event Other Summary report: N

    KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX

    MDR report key: 1652376 · Received April 5, 2010

    Report

    Report Number
    1226001-2010-00010
    Event Type
    Other
    Date Received
    April 5, 2010
    Date of Event
    November 16, 2009
    Report Date
    March 22, 2010
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Product Code
    GXP
    PMA / PMN Number
    K091382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR WHAT MAY HAVE CONTRIBUTED TO THIS EVENT. THERE ARE SEVERAL FACTORS THAT MAY HAVE PLAYED A ROLE IN NOT ALLOWING THE KRYPTONITE-X MATERIAL TO FULLY HARDEN, INCLUDING BUT NOT LIMITED TO; INSUFFICIENT OR IMPROPER SITE PREPARATION, TOO MUCH BLOOD WITHIN SURGICAL SITE, OR IMPROPER MIXING. IT WOULD ALSO APPEAR THAT THE USE OF KRYPTONITE IN THIS SURGICAL PROCEDURE/CONDITION WOULD NOT HAVE BEEN APPROPRIATE. KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX IS NOT INDICATED FOR USE WERE INTRINSIC STABILITY TO THE BONY STRUCTURE IS REQUIRED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE IDENTIFIED PRODUCT AND PRODUCT CODE IS DESIGNATED FOR EXPORT ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX WAS USED IN A REVISION SURGERY WHERE A HUMERAL NAIL WAS REVISED TO A TOTAL SHOULDER REPLACEMENT. THE HUMERAL STEM WAS PAINTED WITH KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX AND IMPLANTED AS A PRESS FIT. A REVIEW OF THE X-RAY SHOWED EXPANSION OUT OF THE DISTAL SCREW HOLES. THIS EXPANSION CREATED SOME DISCOMFORT/IRRITATION TO THE PATIENT. AT 3 MONTHS POST-OP, IT WAS REMOVED AND THE KRYPTONITE WAS OBSERVED TO BE PUTTY IN CONSISTENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KRYPTONITE-X RADIOPAQUE LIQUID BONE COMPLEX BONE CEMENT GXP DOCTOR'S RESEARCH GROUP, INC. KRYP-X-10 05272009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN