BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE

    MDR report key: 4172822 · Received October 10, 2014

    Report

    Report Number
    1226188-2014-00068
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 18, 2014
    Manufacturer
    OMILIFE SCIENCES, IN
    Product Code
    JWH
    PMA / PMN Number
    K112891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT MADE NO INDICATION OF ANY OMNILIFE SCIENCE DEVICE MALFUNCTION OR DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR DEVICE PERFORMANCE CONTRIBUTING TO THE ADVERSE EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE EXPLANTED DEVICES REVEALED NO DEVIATION FROM PROCESS OF NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THE COMPLAINT INVOLVED A PT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2014. THE ORIGINAL SURGERY WAS DATED (B)(6) 2013. THE REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION. THE SURGEON REMOVED THE POLY COMPONENT AND ASSOCIATED LOCKING BOLT. THE ULTRA TIBIAL INSERT AND RETAINING BOLT WERE REVISED TO NEW IMPLANTS OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642608 APEX KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIA JWH OMILIFE SCIENCES, IN 10107

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R