BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOACTION FIRST MPJ

    MDR report key: 1625982 · Received March 3, 2010

    Report

    Report Number
    2027754-2010-00003
    Event Type
    Other
    Date Received
    March 3, 2010
    Report Date
    February 26, 2010
    Manufacturer
    OSTEOMED LP
    Product Code
    LZJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR FAILED TO USE PRODUCT IN ACCORDANCE WITH IFU. DOCTOR DID NOT USE BONE CEMENT AND USED DIFFERENT APPROACH THAN RECOMMENDED. IMPLANT IS FOR CEMENTED USE ONLY. IMPLANTS NOT RETURNED TO COMPANY. NO MEDICAL FILES AVAILABLE. THIS IS INFO EXTRACTED FROM A PUBLISHED JOURNAL ARTICLE.

    Description of Event or Problem · 1

    ARTICLE PUBLISHED IN FOOT AND ANKLE SURGERY, (B)(6) 2010, PGS 25 - 27 TALKS ABOUT THE SURVIVORSHIP OF THE BIOACTION MPJ ARTHROPLASTY FOR HALLUX RIGIDUS, 5 YR F/U. STUDY INCLUDES 14 PTS TREATED BY THE SAME DOCTOR. BASED ON THE 5 YR F/U, THE IMPLANTS SHOWED RADIOGRAPHIC SIGNS OF LOOSENING AND IN TWO PTS IMPLANT REMOVAL AND ARTHRODESIS WAS PERFORMED FOR INCREASING TOE PAIN AT 61 AND 63 MONTHS RESPECTIVELY. THE STUDY STATES THE IMPLANTS WERE PLACED USING A MEDIAL APPROACH AND THAT NO BONE CEMENT WAS USED. THE IFU CLEARLY STATES THAT THE APPROACH SHOULD BE DORSAL, AND THAT THE IMPLANTS ARE FOR CEMENTED USE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOACTION FIRST MPJ GREAT TOE IMPLANT LZJ OSTEOMED LP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention