Software-related recalls in computer-assisted hip and knee arthroplasty.

Journal: International orthopaedics
Published Date: Mar 1, 2023

Abstract

PURPOSE: Computer-assisted arthroplasty supports the surgeons in planning, simulating, and performing the replacement procedure, using robotic or navigation technologies. However, the safety of the technology has not been widely ascertained. Food and Drug Administration (FDA) database was interrogated about software-related recalls in computer-assisted arthroplasty, aiming to assess: (1) the incidence, (2) the root causes, and (3) the actions taken due to recalls.

Authors

  • Francesco Castagnini
    Ortopedia-Traumatologia e Chirurgia protesica e dei reimpianti d'anca e di ginocchio, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136, Bologna, Italy. francescocastagnini@hotmail.it.
  • Marco Maestri
    Ortopedia-Traumatologia e Chirurgia protesica e dei reimpianti d'anca e di ginocchio, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136, Bologna, Italy.
  • Enrico Tassinari
    Ortopedia-Traumatologia e Chirurgia protesica e dei reimpianti d'anca e di ginocchio, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136, Bologna, Italy.
  • Claudio Masetti
    Ortopedia-Traumatologia e Chirurgia protesica e dei reimpianti d'anca e di ginocchio, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136, Bologna, Italy.
  • Cesare Faldini
    Clinica Ortopedica e Traumatologica I, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136, Bologna, Italy.
  • Francesco Traina
    Ortopedia-Traumatologia e Chirurgia protesica e dei reimpianti d'anca e di ginocchio, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136, Bologna, Italy.

Keywords

External Resources

Popular Topics
Recent Journals