BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 968520 · Received December 21, 2007

    Report

    Report Number
    1226188-2007-00015
    Event Type
    Injury
    Date Received
    December 21, 2007
    Date of Event
    November 6, 2007
    Report Date
    December 19, 2007
    Manufacturer
    OMN LIFE SCIENCE INC
    Product Code
    LPH
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER DEVICES USED: NECK, MEDIUM 47.5 LOT 702; 32MM + 7MM HEAD LOT 359; 56MM SHELL LOT 870; INSERT 56-58MM/32, O DEGREE LOT 782.

    Description of Event or Problem · 1

    PT HAD AN INFECTED HIP TWO YRS AFTER PRIMARY TOTAL HIP SURGERY. DURING SURGERY, IT WAS NOTED THAT THE STEM AND CUP WERE WELL FIXED AND FUNCTIONING. ALL IMPLANTS WERE REMOVED AND AN ANTIBIOTIC CEMENT SPACER WAS PLACED TO TREAT THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM LPH OMN LIFE SCIENCE INC SIZE 3X10 STEM 731

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention