BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARC HIP SYSTEM

    MDR report key: 2960437 · Received February 7, 2013

    Report

    Report Number
    1226188-2013-00009
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    OMNLIFE SCIENCE
    Product Code
    LZO
    PMA / PMN Number
    K090845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING THE ORIGINAL SURGERY ((B)(6) 2012) THE FEMUR WAS CLEARED WITH A #3 BROACH (IT WAS ASSUMED THE SURGEON MEANT RASP), BUT THE HOLE COULD NOT BE MADE DEEP ENOUGH TO PERMIT IMPLANT OF A #3 IMPLANT SO A #2 IMPLANT WAS USED. THE 11 MONTH POST-OP X-RAY SHOWS THE DISTAL END OF THE IMPLANT VERY CLOSE TO THE OUTSIDE SURFACE OF THE BONE AND A GAP AT THE TOP (PROXIMAL) END. IT WAS CONCLUDED THAT THE REASON FOR THE LOOSENING WAS DUE TO SURGEON TECHNIQUE AND NOT A FAILURE OF THE DEVICE. THE IMPLANT WAS NOT RETURNED FOR EXAMINATION; THEREFORE, OMNI COULD NOT CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED. BASED ON THE INFO PROVIDED, A REVIEW OF MFG AND STERILIZATION RECORDS WAS PERFORMED AND THERE WAS NO EVIDENCE IN THE FILES THAT SHOWED A CORRELATION THAT WOULD LIKELY RESULT IN THE IMPLANT LOOSENING. ALL BATCH RECORDS, STERILIZATION AND STERILITY RESULTS WERE REVIEWED. THERE WERE NO DEVIATIONS REPORTED THAT WOULD EXPLAIN A LOOSE IMPLANT. REVIEW OF THE X-RAY STRONGLY SUGGESTS THAT THE PROBLEM WAS RELATED TO SURGEON TECHNIQUE.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT PATIENT EXPERIENCED LOOSENING OF ARC HIP IMPLANT AND PAIN. INITIAL SURGERY WAS ON (B)(6) 2012. THE SURGEON REMOVED THE OMNI IMPLANTS AND REPLACED THEM WITH ANOTHER MFR¿S IMPLANTS ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51421 ARC HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED LZO OMNLIFE SCIENCE 8997

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R