BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIRSCHNER INTEGRITY PROSTHESIS, HIP, ACETABULAR

    MDR report key: 259005 · Received January 13, 2000

    Report

    Report Number
    259005
    Event Type
    Injury
    Date Received
    January 13, 2000
    Date of Event
    November 10, 1999
    Report Date
    November 23, 1999
    Manufacturer
    EBI MEDICAL SYSTEMS INC. SUB BIOMET INC
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH COMPLAINT OF DISLOCATED RIGHT TOTAL HIP REPLACEMENT. THE ORIGINAL SURGERY WAS DONE IN 1996. THE PR HAD STRETCHED AND SHIFTED POSITIONS IN BED WHEN THE DISLOCATION OCCURRED. THE PT HAD A SIMILAR EVENT WHICH REQUIRED CLOSED REDUCTION UNDER GENERAL ANESTHESIA. AN ATTEMPT AT REDUCTION THIS ADMISSION WAS UNSUCCESSFUL. THE PT WAS TAKEN TO SURGERY IN 1999 FOR REVISION OF THE ACETABULAR COMPONENT TO A CONSTRAINED ACETABULAR PROSTHESIS. AT THE TIME OF SURGERY IT WAS NOTED THAT THERE WAS EASY ANTERIOR DISLOCATION WHERE THE SOFT TISSUE HAD BEEN STRETCHED AND IN ADDITION THE POLYETHYLENE LINER HAD UNDERGONE DEFORMITY AND DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIRSCHNER INTEGRITY PROSTHESIS, HIP, ACETABULAR ACETAB CUP JDI EBI MEDICAL SYSTEMS INC. SUB BIOMET INC * 591020
    2 KIRSCHNER INTEGRITY PROSTHESIS, HIP, ACETABULAR POLYETHYLENE LINER JDI EBI MEDICAL SYSTEMS INC, SUB BIOMET INC * 011522

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R