BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURALOC 28MM ID 10 D POLY GP

    MDR report key: 490725 · Received October 22, 2003

    Report

    Report Number
    1818910-2003-00720
    Event Type
    Injury
    Date Received
    October 22, 2003
    Date of Event
    September 24, 2003
    Report Date
    September 26, 2003
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN MD CAME TO IMPLANT A DURALOC CUP WAS GIVEN A DURALOC OPTION CUP FROM THE HOSP OWN STOCK AND A DURALOC ENDURON LINER FROM THE ORTHOKIT BOX. THESE TWO PRODUCTS ARE NOT DESIGNED TO BE USED TOGETHER IT IS THE INCORRECT LINER FOR THE OPTION CUP. NOTHING ON THE PRODUCT PACKAGING ALERTED MD TO THE FACT THAT THESE TWO ITEMS WERE INCOMPATIBLE AND THE IMPLANTED THEM INTO THE PT. THE LINER, ALTHOUGH NOT DESIGNED FOR OPTION SHELL WAS IMPACTED AND APPEARED TO FIT. THE ERROR CAME TO LIGHT A FEW HOURS AFTER THE SURGERY WHEN REPORTER SPOKE TO THE THEATRE SISTER AND SHE HAPPENED TO MENTION WHICH PRODUCTS HAD BEEN USED. THE SURGEON WAS ALERTED TO THE ERROR MD ELECTED TO RE-OPERATE ON THE PT THE NEXT DAY AND REMOVE THE INCORRECT LINER AND REPLACE IT WITH A OPTION CUP LINER LPW 28 X 54MM AND DYNAMIC LOCKING RING (REF: 159923054, LOT XWG-62). THIS PRODUCT WAS SUPPLIED VIA ORTHOKIT ON THE DAY OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURALOC 28MM ID 10 D POLY GP TOTAL HIP REPLACEMENT KWB DEPUY INTERNATIONAL, LTD. NA 1092019

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention