BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP SYSTEM

    MDR report key: 3032209 · Received March 29, 2013

    Report

    Report Number
    1226188-2013-00023
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    April 24, 2013
    Report Date
    March 5, 2013
    Manufacturer
    OMNLIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY TO SUPPORT: THE IMPLANTS WERE NOT RETURNED FOR EXAMINATION; THEREFORE, OMNI COULD NOT CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED. PHOTOGRAPHS OF THE EXPLANTED FEMORAL STEM AND NECK INDICATE THAT THE NECK BROKE WHERE IT IS MATED WITH THE STEM, AND ALSO THAT THE PIN IN THE STEM BROKE. BASED ON THE INFO PROVIDED, A REVIEW OF MANUFACTURING LOT RECORDS WAS PERFORMED. ALL IMPLANT LOT RECORDS WERE REVIEWED AND NO DEVIATIONS WERE NOTED. THE INFO PROVIDED IS INSUFFICIENT TO PERMIT A CONCLUSION REGARDING THE FAILURE OF THE MODULAR HIP. THE PIN IN THE STEM DID SHEAR, BUT THE LOWER PORTION OF THE NECK ALSO BROKE. IT CANNOT BE DETERMINE WHICH EVENT OCCURRED FIRST OR IF THEY OCCURRED SIMULTANEOUSLY. THIS IS THE FIRST KNOWN COMPLAINT OF PIN SHEAR WHERE THE NECK ALSO BROKE.

    Description of Event or Problem · 1

    A REVISION SURGERY WAS PERFORMED DUE TO A FRACTURE AT THE JUNCTION OF THE MODULAR HIP STEM. THE SURGEON REMOVED THE OMNI IMPLANTS AND REPLACED THEM WITH NON OMNI IMPLANTS. THE REMOVED IMPLANTS WERE NOT RETURNED TO OMNI. INITIAL SURGERY WAS ON (B)(6) 2004 AND REVISION SURGERY WAS ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131159 APEX MODULAR HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED LPH OMNLIFE SCIENCE, INC. 429

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R