BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPRO COX COMB POLY INSERT

    MDR report key: 2267870 · Received September 20, 2011

    Report

    Report Number
    1833506-2011-00001
    Event Type
    Other
    Date Received
    September 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BIOPRO, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HIP STEM SENT BACK BY USER FACILITY WAS NOT MFG BY BIOPRO.

    Description of Event or Problem · 1

    ADD'L INFO TO USER FACILITY REPORT: USER FACILITY REPORT RECEIVED ON (B)(4) 2011. PT INVOLVED IN CAR ACCIDENT WHICH CAUSED TRAUMA, LOOSENING OF HIS IMPLANT AND REVISION SURGERY FOR REPLACEMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPRO COX COMB POLY INSERT HIP SYSTEM COMPONENT JDI BIOPRO, INC. 10077

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R