BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPRO PSL FEMORAL HIP STEM

    MDR report key: 2623340 · Received June 14, 2012

    Report

    Report Number
    1833506-2012-00001
    Event Type
    Malfunction
    Date Received
    June 14, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 14, 2012
    Manufacturer
    BIOPRO INC.
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METALLURGICAL TESTING BEING PERFORMED. PT'S WEIGHT WAS OVER THE WEIGHT RESTRICTION LABELED FOR THE FEMORAL HEAD USED WITH THE HIP STEM, WHICH COULD HAVE CONTRIBUTED TO THE DEVICE FRACTURE.

    Description of Event or Problem · 1

    HIP STEM FRACTURED IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPRO PSL FEMORAL HIP STEM FEMORAL HIP STEM KWY BIOPRO INC. 10121 104211

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention