In the early days of total joint replacement, implant fracture, material problems and wear presented major problems for the long-term success of the operation. Today, failures directly related to the implant comprise only 2-3% of the reasons for revision surgeries, which is a result of the material and design improvements in combination with the standardization of pre-clinical testing methods and the post-market surveillance required by the legal regulation. Arthroplasty registers are very effective tools to document the long-term clinical performance of implants and implantation techniques such as fixation methods in combination with patient characteristics. Revisions due to implant failure are initially not reflected by the registries due to their small number. Explant analysis including patient, clinical and imaging documentation is crucial to identify failure mechanisms early enough to prevent massive failures detectable in the registries. In the past, early reaction was not always successful, since explant analysis studies have either been performed late or the results did not trigger preventive measures until clinical failures affected a substantial number of patients. The identification of implant-related problems is only possible if all failures are reported and related to the number of implantations. A system that analyses all explants from revisions attributed to implant failure is mandatory to reduce failures, allowing improvement of risk assessment in the regulatory process.

中文翻译：

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外植体分析和种植体登记都需要进一步提高患者的安全性。

在全关节置换的早期，植入物断裂、材料问题和磨损是手术长期成功的主要问题。今天，与植入物直接相关的失败仅占翻修手术原因的 2-3%，这是材料和设计改进以及临床前测试方法的标准化和市场后监管要求的结果。法律规定。关节成形术登记册是记录植入物和植入技术（例如固定方法）的长期临床表现与患者特征相结合的非常有效的工具。由于植入失败而导致的修订由于数量较少，最初并未反映在登记处。外植体分析，包括患者，临床和影像记录对于尽早识别故障机制以防止在登记处检测到大规模故障至关重要。过去，早期反应并不总是成功的，因为外植体分析研究要么进行得很晚，要么结果没有触发预防措施，直到临床失败影响到大量患者。只有报告所有故障并与植入次数相关，才能识别植入相关问题。必须建立一个系统来分析归因于植入失败的修正中的所有外植体，以减少失败，从而改进监管过程中的风险评估。因为外植体分析研究要么进行得很晚，要么结果没有触发预防措施，直到临床失败影响到大量患者。只有报告所有故障并与植入次数相关，才能识别植入相关问题。必须建立一个系统来分析归因于植入失败的修正中的所有外植体，以减少失败，从而改进监管过程中的风险评估。因为外植体分析研究要么进行得很晚，要么结果没有触发预防措施，直到临床失败影响到大量患者。只有报告所有故障并与植入次数相关，才能识别植入相关问题。必须建立一个系统来分析归因于植入失败的修正中的所有外植体，以减少失败，从而改进监管过程中的风险评估。