BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 2960425 · Received February 7, 2013

    Report

    Report Number
    1226188-2013-00008
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    OMNLIFE SCIENCE
    Product Code
    JWH
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY TO SUPPORT. THE IMPLANT WAS NOT RETURNED FOR EXAMINATION; THEREFORE, OMNI COULD NOT CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED NOR PERFORM AN INSPECTION OF THE IMPLANT. 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 THE PATIENT FALLING NOR WAS THERE ANY INDICATION OF A DEFECT IN THE IMPLANT. THE SURGEON DID NOT REPORT THAT THE FALL WAS RELATED TO THE IMPLANT. ALL BATCH RECORDS, STERILIZATION AND STERILITY RESULTS WERE REVIEWED. THERE WERE NO DEVIATIONS REPORTED.

    Description of Event or Problem · 1

    PATIENT HAD A TKR ON (B)(6) 2012. SALES REP REPORTED THAT THE PT FELL ON HER KNEE AND NEEDED REVISION SURGERY. THE REVISION SURGERY WAS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51490 APEX KNEE SYSTEM PROSTHESIS, KNEE PATELLO/FEMOROTIBIAL JWH OMNLIFE SCIENCE 10843

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R