BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX HIP SYSTEM

    MDR report key: 3003965 · Received March 12, 2013

    Report

    Report Number
    1226188-2013-00018
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTS WERE NOT RETURNED FOR EXAM AND THEREFORE OMNI COULD NOT CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED. BASED ON THE INFORMATION PROVIDED, A REVIEW OF MANUFACTURING LOT RECORDS WAS PERFORMED. THERE WAS NO EVIDENCE IN THE FILES THAT SHOWED A CORRELATION THAT WOULD LIKELY RESULT IN THE DISLOCATION. ALL IMPLANT LOT RECORDS OF EXPLANTED PRODUCT WERE REVIEWED AND THERE WERE NO DEVIATIONS.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO DISLOCATION OF THE HIP. THE ORIGINAL SURGERY WAS ON (B)(6) 2013 AND THE REVISION SURGERY WAS ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103560 APEX HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED LPH OMNLIFE SCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R