BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MODULAR HIP SYSTEM

    MDR report key: 1581703 · Received December 23, 2009

    Report

    Report Number
    1226188-2009-00031
    Event Type
    Malfunction
    Date Received
    December 23, 2009
    Date of Event
    December 14, 2009
    Report Date
    November 25, 2009
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K031110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MECHANICAL TESTS WERE PERFORMED ON SIMILAR DEVICES.

    Description of Event or Problem · 1

    ORIGINAL SURGERY PERFORMED ON (B)(6)2004. REVISION SCHEDULED FOR LAST WEEK IN (B)(6). THE FOLLOWING FOLLOW UP INFO WAS PROVIDED FROM THE SALES REP: THE REVISION SURGERY WAS CARRIED OUT ON (B)(6)2009. THE PREVIOUS IMPLANT HAD A BROKEN PIN DUE TO WHICH THE REVISION SURGERY WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP SYSTEM HIP PROSTHESIS, UNCEMENTED LPH OMNI LIFE SCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention