BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MODULAR HIP STEM

    MDR report key: 1352270 · Received March 26, 2009

    Report

    Report Number
    1226188-2009-00003
    Event Type
    Injury
    Date Received
    March 26, 2009
    Date of Event
    February 3, 2009
    Report Date
    March 24, 2009
    Manufacturer
    OMNI LIFE SCIENCE, INC.
    Product Code
    KWY
    PMA / PMN Number
    K000788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION POSSIBLE AS PRODUCT NOT RETURNED. ADDITIONAL IMPLANTS: CAT# 200610, NECK, LONG 50, MFG. 4/16/2002, EXP. 4/30/2007.

    Description of Event or Problem · 1

    THA REVISED DUE TO JOINT INSTABILITY 72 MONTHS AFTER ORIGINAL SURGERY. AT SURGERY IT WAS NOTED THAT THE MODULAR NECK WAS STILL IN PLACE ON THE STEM, BUT THE NECK WAS LOOSE, THE ALIGNMENT PIN WAS INTACT BUT THE MATING HOLD IN THE NECK WAS ELONGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MODULAR HIP STEM POROUS FEMORAL STEM KWY OMNI LIFE SCIENCE, INC. SZ 4MMX11.5MM 307

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R