Morlock, MichaelMichaelMorlockKretzer, Jan PhilippeJan PhilippeKretzerSchierjott, Ronja A.Ronja A.SchierjottTraina, FrancescoFrancescoTrainaLarrainzar-Garijo, RicardoRicardoLarrainzar-GarijoDuda, GeorgGeorgDudaKaddick, ChristianChristianKaddick2024-01-042024-01-042023-051st EFORT European Consensus Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices (2023)https://hdl.handle.net/11420/44899Question: Mechanical component testing How can be established from a clinical perspective that the implant will withstand the endurance habitual and peak loads that must reasonably be expected (i.e. single implant parts as well as complete arthroplasty combination)? Summary/Recommendation: Presently catastrophic implant failure as the origin of clinical failure is rare as long as the implant is loaded according to its designed purpose, especially with respect to the load transfer between implant and bone. Aspects to be considered are: • The execution of established and standardized pre-clinical testing methods for the determination of strength and endurance properties are the essential basis for successful pre-clinical assessment. These have to be performed under physiological conditions (i.e. considering the pH-value in the body and potential corrosion processes, especially for implants with interfaces such as modular implants – see also Consensus Statement 13: Modularities / Interfaces) and worst-case size combinations (e.g. based on FEA). • The combination matrix for implant systems (size range of component 1 compatible with size range of component 2) has to be respected in the clinical application to avoid failure due to overloading (e.g. for TKA components to find suitable size combinations and avoid failure of PE inserts due to mechanical overloading). • Systematic analysis of retrieved implants from clinical studies and specific cases (even if the reason for retrieval was not mechanical failure, the retrievals could be analyzed for potential signs of fatigue) • Careful analysis of registry results (especially for combinations) and their association with patient characteristics and the respective results from pre-clinical testing. • If implants are used in a mix&match combination, which is typically not tested pre-clinically, the potential influence of this combination on overall survival is difficult to assess since frequently not both manufacturers are notified of adverse events. This is one more justification for public registries.enMedicine, HealthEngineering and Applied OperationsResearch Reporthttps://www.efort.org/wp-content/uploads/2023/05/EFORT_Consensus.pdfResearch Report