BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION KNEE

    MDR report key: 3122614 · Received May 15, 2013

    Report

    Report Number
    1644408-2013-00275
    Event Type
    Other
    Date Received
    May 15, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 5, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JWH
    PMA / PMN Number
    K963028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY ON (B)(6) 2013 WAS IDENTIFIED AS AN INFECTION. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2013, 25 DAYS PRIOR TO THE REVISION. 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 BY THE HOSPITAL AND NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. THE DEVICE HISTORY RECORDS FOR THE REPORTED COMPONENT INVOLVED WERE EXAMINED. A REVIEW OF THE STERILIZATION RECORDS SHOWS THAT THE REPORTED DEVICE RECEIVED AN ADEQUATE 25-40 KGY GAMMA RADIATION STERILIZATION DOSE AND WAS WITHIN ITS EXPIRATION DATE AT THE TIME OF THE ORIGINAL SURGERY. A REVIEW OF THE IMPLANT DEVICE HISTORY RECORD, PRODUCT COMPLAINT REPORT DATABASE, AND STERILIZATION RECORDS SHOW THIS DEVICE MET STERILIZATION, DESIGN, AND MANUFACTURING REQUIREMENTS. DUE TO THE SHORT TIME BETWEEN THE ORIGINAL SURGERY AND THE REVISION SURGERY IT IS POSSIBLE THAT THE INFECTION WAS ACQUIRED AT THE HOSPITAL (NOSOCOMIAL). IT IS ALSO POSSIBLE THAT THE PATIENT WAS NOT COMPLIANT WITH POST-SURGICAL INSTRUCTIONS. NO INFORMATION WAS SUBMITTED WITH REGARD TO THE SEVERITY OF THE INFECTION. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THE DATA REVIEWED IN THIS REPORT SUPPORTS THIS INCIDENT WAS NOT THE RESULT OF A PRODUCT OR MANUFACTURING PROCESS DEFECT.

    Description of Event or Problem · 1

    REVISION SURGERY - PATIENT HAD INFECTION THAT REQUIRED IRRIGATION AND DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214816 FOUNDATION KNEE ULTRA-CONGRUENT INSERT 9MM CM JWH ENCORE MEDICAL, L.P. 59602599

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention