BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP

    MDR report key: 1665813 · Received April 21, 2010

    Report

    Report Number
    1226188-2010-00007
    Event Type
    Injury
    Date Received
    April 21, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 23, 2010
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE LOT # OF THE PRODUCT WAS NOT PROVIDED TO CARRY OUT A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    REVISION SURGERY CARRIED OUT ON AN IMPLANT THAT WAS ORIGINALLY IMPLANTED IN 2004. EXACT DATE OF ORIGINAL SURGERY IS KNOWN. PT IS SAID TO BE DOING WELL POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP FEMORAL COMPONENT OF THA LPH OMNI LIFE SCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention