BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNISYN HIP SYSTEM

    MDR report key: 535150 · Received July 14, 2004

    Report

    Report Number
    2952369-2004-00002
    Event Type
    Other
    Date Received
    July 14, 2004
    Date of Event
    June 22, 2004
    Report Date
    July 14, 2004
    Manufacturer
    HAYES MEDICAL, INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FRACTURE OF NECK COMPONENT OF A UNISYN HIP IMPLANT. PT MAINTAINS ACTIVE LIFESTYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNISYN HIP SYSTEM HIP PROSTHESIS (NECK, STANDARD, 30X34 MM) LWJ HAYES MEDICAL, INC. NA 470363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FEMORAL STEM, LOCKING NUT, STEM, BODY INPLANTED IN| 2002.