BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISYN TOTAL HIP SYSTEM

    MDR report key: 969559 · Received December 21, 2007

    Report

    Report Number
    2952369-2007-00002
    Event Type
    Injury
    Date Received
    December 21, 2007
    Date of Event
    May 25, 2007
    Report Date
    June 4, 2007
    Manufacturer
    HAYES MEDICAL, INC.
    Product Code
    JDI
    PMA / PMN Number
    003649
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HAYES MEDICAL REVIEWED AND EVALUATED THE DEVICE HISTORY RECORD FOR LOT 470257A. THE DHR DEMONSTRATES THAT THIS LOT WAS PRODUCED IN CONFORMITY WITH ALL PRODUCT, PROCESS AND MATERIAL SPECIFICATIONS. SURGEON CONFIRMED ON EXPLANTATION DURING REVISION SURGERY THAT THE IMPLANT NECK COMPONENT HAD FRACTURED.

    Description of Event or Problem · 1

    REPORT THAT A NECK COMPONENT (CATALOG # 3441-13046-0) OF A UNISYN MODULAR HIP IMPLANT SYSTEM PREVIOUSLY IMPLANTED IN A PATIENT HAD FRACTURED. REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNISYN TOTAL HIP SYSTEM JDI, LZO, MEH JDI HAYES MEDICAL, INC. UNISYN STD. NECK 470257A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention