BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FI

    MDR report key: 132640 · Received November 12, 1997

    Report

    Report Number
    2029012-1997-00101
    Event Type
    Injury
    Date Received
    November 12, 1997
    Date of Event
    July 19, 1995
    Report Date
    November 12, 1997
    Manufacturer
    INTERPORE INTL.
    Product Code
    LMN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THIS PT WAS DIAGNOSED WITH SEPTIC ARTHRITIS OF THE LEFT KNEE. THE PT WAS ALSO DIAGNOSED WITH CELIAC SPRUE AND CHRONIC DIARRHEA 24 HRS A DAY. ON JULY 19, 1995, A CULTURE REPORT SHOWED STAPHYLOCOCCUS AUREUS WHICH GREW FROM THE FLUID TAKEN FROM THE KNEE. ON JULY 21, 1995, THE PT UNDERWENT AN I&D OF THE KNEE, INCLUDING REMOVAL OF THE PRO OSTEON. A REPEAT I&D WAS PERFORMED ON JULY 28, 1995 AND THE PT WAS PLACED ON BACTRIM DS. THE PT HAD POOR HYGIENE AND DID NOT KEEP THE WOUND CLEAN, THEREFORE, THE WOUND BECAME CHRONICALLY INFECTED. THE PT WAS HOMELESS AND HAS A PREVIOUS HISTORY OF IV DRUG AND ALCOHOL ABUSE. BECAUSE OF THE CELIAC SPRUE AND CHRONIC DIARRHEA, THE PT WAS ADVISED TO MAINTAIN A GLUTEN-FREE DIET, HOWEVER, THE PT WAS NOT COMPLIANT. THE PT ELECTED TO HAVE HIS LEG AMPUTATED AND THIS WAS PERFORMED ON SEPTEMBER 8, 1995.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FI Implant ENDOSSEOUS IMPLANT LMN INTERPORE INTL. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization