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.

Preoperative identification of intramuscular hemangioma (IMH) subtypes (capillary hemangioma, cavernous hemangioma, and mixed hemangioma) is urgently necessary. Enhanced T2*-weighted angiography (ESWAN) is sensitive to vessels and metabolites and can be used to diagnose IMH subtypes. To compare the diagnostic performances of ESWAN and conventional magnetic resonance imaging (MRI) for qualitative and quantitative diagnosis of IMH subtypes. In total, 23 patients with IMHs were examined using conventional MRI and ESWAN. The signal intensity ratios (SIRs) of conventional MRI and ESWAN were measured. There was no significant difference for volume among the three subtypes (P = 0.124, P = 0.145). Various shapes and MRI signals were shown in the three subtypes of IMH. There was no significant difference for SIRs of conventional MRI (P = 0.558, P = 0.259, P = 0.385, P = 0.347). However, there was a significant difference for SIRs of ESWAN parameters (P = 0.050, P < 0.001, P = 0.005, P = 0.002). Capillary hemangiomas can be diagnosed when R2* SIR is <0.912 and intratumoral susceptibility signal (ITSS) percentage is 0.912, ITSS percentage >35.226%, and phase SIR >2.536. In addition, mixed hemangiomas should be considered when T2* SIR is >0.662 and R2* SIR <1.618. Conventional MRI can only display the volume, shape, and signal of IMHs. 3D-MinIP imaging of ESWAN can show the veins and minor hemorrhage. SIRs of ESWAN parameters including T2* value, R2* value, phase value, and percentage of ITSS can be used to quantitatively diagnose capillary hemangiomas, cavernous hemangiomas, and mixed hemangiomas.

To evaluate the diagnostic accuracy of a new modified MR dual precision positioning of thin-slice oblique sagittal fat suppression proton density-weighted imaging (DPP-TSO-Sag-FS-PDWI) sequence in detecting ACL injuries and its grades compared to standard sequences using arthroscopy as the standard reference. 42 patients enrolled in this retrospective study received the 1.5-T MRI with standard sequences and the new modified DPP-TSO-Sag-FS-PDWI sequence, and their arthroscopy results was recorded. The Mc Nemer-Bowker and weighted Kappa was performed to compare the consistency of MRI diagnosis with arthroscopic results. Finally, the diagnostic accuracy was calculated based on the true positive, true negative, false negative and false positive values. The diagnostic consistency of the DPP-TSO-Sag-FS-PDWI were higher than standard sequences for both reader 1 (K = 0.876 vs. 0.620) and reader 2 (K = 0.833 vs. 0.683) with good diagnostic repeatability (K = 0.794 vs. 0.598). Furthermore, the DPP-TSO-Sag-FS-PDWI can classify and diagnose three grades of ACL injury [the sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value were more than 84%], especially for grade II injury as the PPV was superior for reader 1 (92.3% vs. 53.9%) and reader 2 (84.6% vs. 69.2%). The new modified DPP-TSO-Sag-FS-PDWI sequence can display the ACL injury on one or continuous levels by maximizing the acquisition of complete ligament shape and true anatomical images, and excluding the influence of anatomical differences between individuals. It can improve the diagnostic accuracy with good repeatability and classify three grades of the ACL injury.

Background: It is still uncertain to determine the exact diagnostic accuracy of MRI for medial meniscus (MM) tear, lateral meniscus (LM) tear and MM posterior root tear (MMPRT) at different magnetic field intensities (MFIs), different sequences and different publication dates. This study aimed to identify the diagnostic performance of MRI for different meniscus lesions at different MFIs, different sequences and different publication dates, and also to compare it with physical examination. Methods: PubMed, Embase, Ovid database, Biosis Previews, Cochrane library, Web of Sciences and manual searching were performed from 1 January 2000 to 31 December 2021. Prospective studies of meniscus injuries examined by physical examination, MRI and arthroscopy were included. Results: Thirteen studies with 1583 meniscal tears were included. The pooled sensitivity, specificity, positive likelihood ratio (LR+), negative likelihood ratio (LR-), diagnostic odds ratio (DOR) and area under curve (AUC) were 87% (95% confidence interval (CI), 86-89%), 82% (80-83%), 7.44 (5.11- 10.75), 0.18 (0.14-0.23), 45.95 (26,68-79.15) and 0.93, respectively. The pooled specificity between MM and LM (p = 0.015), the pooled sensitivity and LR- between MM and MMPR (p = 0.031), different MRI sequences (p = 0.035, p = 0.027), and the accuracy of less than 1.5T and 3.0T (p = 0.04), 1.5T and 3.0T (p = 0.035) were statistically different. There was no publication bias (p = 0.54). Conclusion: MRI performed well in the diagnosis of MM tear, LM tear and MMPRT, and the diagnostic performance of physical examination is similar to MRI. The diagnostic accuracy of 3.0T is the highest, and the -weighted imaging (SWI) sequence may be beneficial for diagnosing meniscus tear. However, there are not enough evidence to prove that recent studies are significantly better than previous ones.