BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURIST

    MDR report key: 10546839 · Received September 17, 2020

    Report

    Report Number
    3009611746-2020-00001
    Event Type
    Injury
    Date Received
    September 17, 2020
    Date of Event
    August 17, 2020
    Report Date
    August 24, 2020
    Manufacturer
    JOSSI AG
    Product Code
    FWZ
    PMA / PMN Number
    NA#S-P#NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER STATED THAT THE PATIENT HAD POOR BONE QUALITY (OSTEOPOROTIC) AND HAD MULTIPLE CO-MORBIDITIES. USE OF THE PURIST TABLE ON OSTEOPOROTIC PATIENTS IS CAUTIONED IN THE OPERATION MANUAL. THE MANUAL STATES THAT LEG FRACTURES MAY OCCUR IF EXCESSIVE MECHANICAL FORCE IS APPLIED TO THE BONES OF OSTEOPOROTIC PATIENTS BY ROTATION OF THE LEG. IN THIS CASE, THE REPORTER STATES THAT THE FEMUR WAS EXTERNALLY ROTATED TO 80 DEGREES AND THEN ABDUCTED AT WHICH POINT THE LEG MADE AN AUDIBLE "POP" SOUND. THE SURGEON REPORTED THAT PURIST TABLE WAS WORKING AS INTENDED. BASED ON THIS INFORMATION, THE ADVERSE EVENT IS SUSPECTED TO BE RELATED TO THE PATIENT CONDITION; THIS ADVERSE EVENT IS A KNOWN HARM OF OSTEOPOROTIC PATIENTS.

    Description of Event or Problem · 1

    PATIENT'S TIBIA WAS FRACTURED DURING A DIRECT ANTERIOR APPROACH TOTAL HIP REPLACEMENT PROCEDURE USING THE PURIST TABLE WHEN THE LEG WAS EXTERNALLY ROTATED AND THEN ABDUCTED. THE FRACTURE WAS TREATED NON-SURGICALLY AND THEN PLACED INTO A PLASTER CAST. THE SURGEON REPORTED THAT PURIST TABLE WAS WORKING AS INTENDED. THE PATIENT HAD POOR BONE QUALITY (OSTEOPOROTIC) AND HAD MULTIPLE CO-MORBIDITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011159 PURIST PURIST LEG POSITIONING TABLE FWZ JOSSI AG 6813100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other CANNULATED SCREWS| POROUS POLARSTEM| STRIKER ACETABULAR MESH| ZIMMER DHS