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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.
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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.
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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.
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Revisions due to implant failure are initially not reflected by the registries due to their small number.
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Explant analysis including patient, clinical and imaging documentation is crucial to identify failure mechanisms early enough to prevent massive failures detectable in the registries.
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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.
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The identification of implant-related problems is only possible if all failures are reported and related to the number of implantations.
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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.
