BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURIST

    MDR report key: 17415327 · Received July 28, 2023

    Report

    Report Number
    3009611746-2023-00001
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    March 23, 2023
    Report Date
    July 28, 2023
    Manufacturer
    JOSSI AG
    Product Code
    BWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INVESTIGATION, THE FOLLOWING ITEMS HAD BEEN CHECKED : TRAINING OF THE USERS, STATE OF FUNCTIONING OF THE DEVICE, STATE OF HEALTH OF THE PATIENT INCLUDING BONE QUALITY, FOLLOWING THE IFU AND SURGICAL PROCEDURE. NO FAILURES OR DEVIATIONS WERE FOUND . SO, THE CAUSE OF THE BONE FRACTURE IS UNKNOWN AND MAY BE LINKED TO THE BONE QUALITY OF THE PATIENT. THIS CASE SEEMS TO BE AN ISOLATED CASE.

    Description of Event or Problem · 0

    A FEW DAYS AFTER A HIP REPLACEMENT SURGERY THAT WAS PERFORMED ON (B)(6) 2023, A FRACTURE OF THE PATIENT'S MALLEOLUS WAS DETECTED. THE SURGEON EXPRESSED A SUSPICION THAT THE FRACTURE MAY HAVE BEEN CREATED DURING THE HANDLING OF THE PATIENT'S LEG THAT WAS PERFORMED WITH THE HELP OF THE PURIST LEG POSITIONER. IT IS UNCLEAR WHAT ACTUALLY CAUSED THE FRACTURE. A PLASTER CAST HAS BEEN APPLIED TO THE PATIENT. THE PATIENT IS A 77-YEAR-OLD WOMAN WITH NORMAL-SIZED FEET. NO MALFUNCTION OF THE PURIST LEG POSITIONER WAS OBSERVED. THE SURGEON NOTIFIED THE MANUFACTURER ON JULY 5, 2023 OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337336 PURIST TABLE AND ATTACHMENTS - OPERATING ROOM- LEG POSITIONING SYSTEM BWN JOSSI AG 6813100.0158

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other