BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPRO PSL HIP STEM

    MDR report key: 5179056 · Received October 26, 2015

    Report

    Report Number
    1832656-2015-00001
    Event Type
    Malfunction
    Date Received
    October 26, 2015
    Date of Event
    October 20, 2015
    Report Date
    October 22, 2015
    Manufacturer
    BIOPRO INC
    Product Code
    LPH
    UDI-DI
    M209170440
    PMA / PMN Number
    K922500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WAITING FOR PHYSICIAN'S DETERMINATION IF THE DEVICE WILL BE REMOVED, SO THE EXPLANTED DEVICE CAN BE EXAMINED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT WENT TO DOCTOR'S OFFICE WITH PAIN IN THE HIP. X-RAYS WERE DONE TO DIAGNOSE THE SOURCE OF THE PAIN AND IT WAS DISCOVERED THAT THE HIP STEM WAS BROKEN. THE DOCTOR INDICATED THAT THE PATIENT HAS GAINED A SIGNIFICANT AMOUNT OF WEIGHT SINCE THE HIP WAS IMPLANTED AND THAT HE SUFFERS FROM MULTIPLE MEDICAL ISSUES. THE DOCTOR WAS TOLD THAT SOMEONE HAD SAT ON THE PATIENT'S LEG IN AN ATTEMPT TO RESTRAIN HIM AT SOME POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708780 BIOPRO PSL HIP STEM FEMORAL HIP STEM LPH BIOPRO INC 17044 109675 M209170440

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention