BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM - PS-R

    MDR report key: 3003886 · Received March 12, 2013

    Report

    Report Number
    1226188-2013-00017
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 21, 2013
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K112891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY TO SUPPORT: THE IMPLANTS WERE NOT RETURNED FOR EXAMINATION AND THEREFORE OMNI COULD NOT CONFIRM THE LOT NUMBER OF THE PRODUCT REPORTED. BASED ON THE INFO PROVIDED, A REVIEW OF MANUFACTURING STERILIZATION RECORDS OF THE EXPLANTED IMPLANTS WAS PERFORMED. THERE WAS NO EVIDENCE IN THE FILES THAT SHOWED A CORRELATION THAT WOULD LIKELY RESULT IN WOUND DRAINAGE. ALL BATCH RECORDS, STERILIZATION AND STERILITY RESULTS WERE REVIEWED. THERE WERE NO DEFECTS OR DEVIATIONS REPORTED.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT A KNEE REVISION SURGERY DUE TO THE WOUND STILL DRAINING TWO WEEKS AFTER SURGERY. THE SALES REP REPORTED THAT CULTURES INDICATED THERE WAS NO INFECTION. WHILE THE SURGEON HAD THE KNEE JOINT EXPOSED, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW ONES. THE ORIGINAL SURGERY WAS ON (B)(6) 2013 AND THE REVISION SURGERY WAS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102985 APEX KNEE SYSTEM - PS-R PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNLIFE SCIENCE, INC. 9954

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R