BEUDAMED
    FDA Adverse Event Other Summary report: N

    FMP HIP

    MDR report key: 3224400 · Received July 10, 2013

    Report

    Report Number
    1644408-2013-00365
    Event Type
    Other
    Date Received
    July 10, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 22, 2013
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    PMA / PMN Number
    K974093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013 AN AGENT REPORTED THAT DURING A REVISION SURGERY AN OTI NECK BROKE, THE LINER AND STEM WERE REMOVED AND REPLACED WITH A STRYKER STEM AND DJO SURGICAL LINER. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2002 MEANING THE COMPONENTS WERE IN-VIVO FOR APPROXIMATELY 11 YEARS. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT ACTIVITY LEVEL, TRAUMA, DISEASE, IMPLANT POSITIONING, AND GENERAL HEALTH THAT COULD HAVE CONTRIBUTED TO THE PRODUCT FAILURE. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. THE ROOT CAUSE FOR THE REVISION SURGERY IS LISTED AS A NECK FRACTURE OF A NON DJO SURGICAL COMPONENT. BECAUSE NO COMPONENTS WERE RETURNED A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT DESIGN OR MANUFACTURING PROBLEM AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO BROKEN NECK ON THE OTI STEM. THE SURGEON REMOVED THE LINER AND THE OTI STEM, AND REPLACED THEM WITH A STRYKER STEM AND DJO LINER. THE ORIGINAL 56MM SHELL REMAINED IN PATIENT, (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317683 FMP HIP LINER - NEUTRAL, MP 9 LPH ENCORE MEDICAL, L.P. 691201

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention