BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK HIP IMPLANT

    MDR report key: 441319 · Received February 4, 2003

    Report

    Report Number
    1818910-2003-00047
    Event Type
    Other
    Date Received
    February 4, 2003
    Date of Event
    January 7, 2003
    Report Date
    February 4, 2003
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ADMITTED TO THE HOSP FOR REVISION OF A LEFT TOTAL HIP ARTHROPLASTY WITH BONE GRAFT. DURING THE COURSE OF THE PROCEDURE; IT WAS DISCOVERED THAT THE SURGICAL PROSTHESIS PACKAGE DID NOT CONTAIN THE PROPER FEMORAL HEAD AND NECK TRUNION COMPONENTS. SURGERY WAS ABANDONED AND A RE-OPERATION WAS CONDUCTED LATER THAT DAY WHEN THE PROSTHESIS COMPONENTS WERE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK HIP IMPLANT TOTAL HIP PROSTHESIS JDI DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other