BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSEM

    MDR report key: 6106845 · Received November 16, 2016

    Report

    Report Number
    1226188-2016-00092
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 13, 2016
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    JWH
    PMA / PMN Number
    K073602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2016. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF PATIENT PAIN. DURING THE REVISION, ALL OF THE ORIGINAL OMNI COMPONENTS WERE REMOVED AND REVISED TO NON-OMNI PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756116 APEX KNEE SYSEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL JWH OMNILIFE SCIENCE, INC. 20784

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R