BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURA DURATION A/P TIB MED 9

    MDR report key: 3830859 · Received May 23, 2014

    Report

    Report Number
    0002249697-2014-01940
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K032163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A DURA DURATION A/P TIB MED 9 WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. REVIEW OF MEDICAL RECORDS BY A CLINICIAN INDICATED THAT THE ELEVATED ESR AND CRP LEVELS ARE CONSISTENT WITH INFECTION. THE EVENT IS NOT DEVICE RELATED. A DEVICE HISTORY REVIEW INDICATED THAT THE SPECIFIED LOT WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 6630-0-325, LOT GHJ0U, DESCRIPTION: DCON STD N-BEAD FEM RHT M. CAT 6632-3-615, LOT GANCB, DESCRIPTION: DURACON UNIVERSAL B/P NON-BEADED. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS MANY MEDICAL ISSUES AND PRESENTED WITH AN INFECTION ON THE RIGHT SIDE OF A PRIMARY DURACON TOTAL KNEE THAT WAS IMPLANTED APPROXIMATELY 18 YEARS PRIOR. SHE HAD HER LEFT SIDE REVISED IN (B)(6) 2013 FOR INFECTION AS WELL. COMPETETOR TEMPORARY SPACER IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS MANY MEDICAL ISSUES AND PRESENTED WITH AN INFECTION ON THE RIGHT SIDE OF A PRIMARY DURACON TOTAL KNEE THAT WAS IMPLANTED APPROXIMATELY 18 YEARS PRIOR. SHE HAD HER LEFT SIDE REVISED IN (B)(6) 2013 FOR INFECTION AS WELL. COMPETETOR TEMPORARY SPACER IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307417 DURA DURATION A/P TIB MED 9 IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention