BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX K1 HIP STEM

    MDR report key: 1987650 · Received January 20, 2011

    Report

    Report Number
    1226188-2010-00019
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    December 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    LPH
    PMA / PMN Number
    K060072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT IS NOT ASSOCIATED WITH DEFECTIVE PRODUCT. USE ERROR MAY HAVE CAUSED 45 MINUTE DELAY IN SURGERY.

    Description of Event or Problem · 1

    PT ADMITTED TO HOSPITAL ON (B)(6), 2010 FOR PRIMARY RIGHT HIP REPLACEMENT. SURGEON BROACHED FOR SIZE 8 LATERAL K1 HIP STEM. IMPLANTED STEM AND STEM SUBSIDED. SURGEON THEN BROACHED FOR SIZE 9 LATERAL STEM WHICH WAS ALSO IMPLANTED AND SUBSIDED CAUSING A 45 MINUTE DELAY IN SURGERY. SURGEON SUCCESSFULLY COMPLETED SURGERY WITH A K1 MONOBLOCK STEM SIZE 10 LAT +. PT EXPERIENCED NO PROBLEMS POST SURGERY AND RELEASED FROM HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX K1 HIP STEM HIP STEM LPH OMNI LIFE SCIENCE, INC. 2497

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention