BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPRO PSL HIP STEM

    MDR report key: 10214464 · Received June 30, 2020

    Report

    Report Number
    1832656-2020-00004
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    June 25, 2020
    Report Date
    June 30, 2020
    Manufacturer
    BIOPRO, INC
    Product Code
    LPH
    UDI-DI
    M209170430
    PMA / PMN Number
    K922500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 6/25/2020 BIOPRO WAS NOTIFIED OF A FAILED EXTRA SHORT HIP STEM. THE STEM WAS IMPLANTED ON (B)(6) 2009. AN ADDITIONAL PHONE CALL WAS HELD WITH THE SURGEON ON 6/29/2020 TO GATHER MORE INFORMATION. THE PATIENT WAS EXPERIENCING PAIN FOR QUITE A WHILE, BUT WAS WALKING. WHEN SHE EXPLAINED THE PAIN AN X-RAY WAS PERFORMED AND THE FRACTURE OF THE HIP STEM WAS EVIDENT. SHE INDICATED THAT 2 YEARS PREVIOUSLY SHE HAD SUFFERED A FALL. UPON REVIEW OF AN X-RAY TAKEN IN 2019 A HAIR LINE FRACTURE IN THE HIP STEM WAS EVIDENT, BUT NOT NOTED AT THE TIME OF THE X-RAY. IT IS UNKNOWN WHEN THE HIP STEM FAILED, BUT REMODELING OF THE BONE AROUND THE DISTAL END OF THE IMPLANT IS INDICATIVE OF THE IMPLANT MOVING WITHIN THE BONE FOR AN EXTENDED PERIOD OF TIME. ADDITIONALLY, WHEN THIS HIP WAS IMPLANTED IN 2009 THE SURGEON UTILIZED A TECHNIQUE WHICH RESULTED IN THE HIP STEM REMAINING SOMEWHAT MORE PROXIMAL, THE SURGEON HAS SINCE MODIFIED HIS IMPLANT TECHNIQUE. THE HIP WILL BE REMOVED AND WILL BE EXAMINED WHEN IT IS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675487 BIOPRO PSL HIP STEM HIP STEM LPH BIOPRO, INC 17043 106473 M209170430

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention