BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOACTION TOE SYSTEM

    MDR report key: 1555852 · Received November 13, 2009

    Report

    Report Number
    2027754-2009-00010
    Event Type
    Injury
    Date Received
    November 13, 2009
    Date of Event
    July 7, 2009
    Report Date
    November 13, 2009
    Manufacturer
    OSTEOMED L.P.
    Product Code
    LZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DOCTOR DISPOSED OFF DEVICE AFTER EXPLANT AND THE DEVICE IS NOT AVAILABLE FOR EVALUATION. DOCTOR DID NOT USE BONE CEMENT WHEN PLACING THE DEVICE. INSTRUCTIONS FOR USE CLEARLY STATE THAT IT IS INTENDED FOR USE WITH BONE CEMENT ONLY.

    Description of Event or Problem · 1

    THE PT COMPLAINED OF "INFLATION" AND IRRITATION FROM INITIAL IMPLANTATION. INITIAL X-RAYS SHOWED PROPER IMPLANT POSITIONING BUT, OVER TIME, A SLIGHT "HALO" DEVELOPED AROUND THE ROOT OF THE IMPLANT. THIS INDICATED POOR BONE-TO-IMPLANT CONTACT. OVER THE NEXT YEAR, THE IMPLANT LOOSENED FURTHER RESULTING IN COMPLETE LOOSENING AND REMOVAL ON (B) (6) 2009. NO BONE CEMENT WAS USED. INSTRUCTIONS FOR USE STATE THAT DEVICE IS ONLY TO BE USED WITH BONE CEMENT. IMPLANT WAS DISPOSED OFF AFTER EXPLANT. DOCTOR DECIDED TO LEAVE THE JOINT UNFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOACTION TOE SYSTEM 1ST MPJ JOINT LZJ OSTEOMED L.P. 350X UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention DOC. DID NOT USE BONE CEMENT AS RECOMMENDED IN IFU