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Background: Medical devices are used in almost all orthopedic surgical subspecialties, and the frequency of adverse events is increasing, which should not be ignored. To provide suggestions on how to avoid implant recalls from the perspective of manufacturers, medical institutions and supervisions, as well as how to respond promptly to adverse events. Methods: The research extracted recalls of osteosynthesis implants and joint replacement implants from January 1, 2011, to June 30, 2021, in the CNMPA, FDA, HC and ATGA websites and collected the information on device name, recall time, recall class, recall manufacturer, device classification and affected areas. Moreover, the McKinsey 7S model and fishbone diagram were used to analyze recall reasons. Results: A total of 315 cases of osteosynthesis implants and 286 cases of joint replacement implants were reported in China, the USA, Canada and Australia. The recalls number from 2016 to 2021 was more than that from 2011 to 2015 for osteosynthesis implant (p = 0.012) and joint replacement implant (p = 0.002), and both mainly focused on class II (76.19% and 78.32%). There were statistical differences in the four countries for both implants (p = 0.000), especially osteosynthesis implant between China and the USA (p = 0.000), China and Canada (p = 0.001), the USA and Australia (p = 0.002), and joint replacement implant between China and Australia (p = 0.000). Conclusions: To avoid the recalls of such implants, manufacturers should strictly select implant materials and components, develop detailed labels and instructions, severely control the packaging process and establish the integrity of medical device data. Medical institutions should standardize procurement procedures, use qualified equipment and train medical workers. It also requires supervisions to conduct premarket safety assessments. In addition, regulators should strengthen supervision and establish reporting systems to deal with the occurrence of adverse events promptly. [ABSTRACT FROM AUTHOR]

Purpose: To assess the native and the previously Rasch-modified National Eye Institute Visual Function Questionnaire (NEI VFQ) scales in a Chinese population., Setting: Eye Hospital of Wenzhou Medical University, Wenzhou, China., Design: Questionnaire development., Methods: Patients on the waiting list for cataract surgery completed the 39-item NEI VFQ (NEI VFQ-39). Rasch analysis was performed in 3 steps as follows: (1) Assess the psychometric properties of the original NEI VFQ. (2) Reassess the previously proposed Rasch-modified NEI VFQ scales by Pesudovs et al. (2010) in Chinese populations. (3) Compare the scores of previously recommended scales of the NEI VFQ with new Rasch-modified scales of the same questionnaire using Bland-Altman plots., Results: Four hundred thirty-five patients (median age 70 years; range 35 to 90 years) completed the NEI VFQ-39. Response categories for 4 question types were dysfunctional and therefore repaired. The original NEI VFQ-39 and NEI VFQ-25 showed good measurement precision. However, both versions showed multidimensionality, misfitting items, suboptimum targeting, and nonfunctioning subscales. Using the previously proposed Rasch-modified scales of the NEI VFQ yielded valid measurement of each construct in the 39-item and 25-item questionnaire. Comparison between the earlier proposed NEI VFQ scales and the new versions developed in this population showed good agreement., Conclusions: The original NEI VFQ was once again found to be flawed. The previously proposed Rasch-analyzed versions of the NEI VFQ and the new Chinese versions showed good agreement., (Copyright © 2014 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.)