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Risk Assessment of Individualized 3D Printed Prostheses Using Failure Mode and Effect Analysis


[ 1 ] Instytut Technologii Materiałów, Wydział Inżynierii Mechanicznej, Politechnika Poznańska | [ 2 ] Wydział Inżynierii Mechanicznej, Politechnika Poznańska | [ P ] employee | [ S ] student

Scientific discipline (Law 2.0)

[2.8] Mechanical engineering

Year of publication


Published in

Advances in Science and Technology Research Journal

Journal year: 2022 | Journal volume: vol. 16 | Journal number: no. 4

Article type

scientific article

Publication language


  • 3D printing
  • prosthetics
  • risk assessment

EN Risk analysis of personalized medical devices, such as prostheses, is a challenging task due to the complexity of technological and geometrical issues. The paper undertakes a process of risk analysis for upper limb prostheses for adult patients, individualized by 3D scanning and produced by additive manufacturing. The analysis was performed to systematize the process and its steps, as well as diagnose certain problems, in order to achieve future devices with correct fit and function, produced in as few iterations as possible. The Failure Mode and Effect Analysis of Process (PFMEA) method was used. In the results, main process risks were identified: the problems are mostly caused in stages, where operator’s decision or activity is to be performed, regarding socket length, offset and suitable lining. The main prevention activities were determined – human involvement in the decision process should be minimal and the intelligent models should be adjustable to as many patient cases as possible. In consequence, future steps for process optimization were determined – larger base of patient cases is necessary to acquire and study, to gather data for model and process improvement.

Date of online publication


Pages (from - to)

189 - 200




License type

CC BY (attribution alone)

Open Access Mode

open journal

Open Access Text Version

final published version

Date of Open Access to the publication

at the time of publication

Ministry points / journal


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