BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 2954204 · Received February 4, 2013

    Report

    Report Number
    1226188-2013-00007
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 15, 2013
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY TO SUPPORT: THE IMPLANT WAS NOT RETURNED FOR EXAMINATION AND THEREFORE OMNI COULD NOT CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED. BASED ON THE INFO PROVIDED, A REVIEW OF MFG AND STERILIZATION RECORDS WAS PERFORMED AND THERE WAS NO EVIDENCE IN THE FILES THAT SHOWED A CORRELATION THAT WOULD LIKELY RESULT IN PT INFECTION. ALL BATCH RECORDS, STERILIZATION AND STERILITY RESULT WERE REVIEWED. THERE WERE NO DEVIATIONS REPORTED. MORE THAN TWENTY-THREE (23) MONTHS HAD TRANSPIRED SINCE THE IMPLANTATION AND THERE WAS NO INDICATION FROM THE SURGEON THAT THE INFECTION WAS RELATED TO THE IMPLANT.

    Description of Event or Problem · 1

    PT HAD A REVISION SURGERY DUE TO AN INFECTION OF THE RIGHT KNEE. ORIGINAL IMPLANT SURGERY WAS ON (B)(6) 2011 AND REVISION SURGERY WAS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45969 APEX KNEE SYSTEM DOVETAIL CONGRUENT TIBIAL INSERT CR JWH OMNLIFE SCIENCE, INC. 3X10 MM 6957

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R