ArticleActa orthopaedica2025
Frequency of safety signals from scientific reports, manufactures, registers, and other sources for a random selection of hip and knee prostheses.
Article in Acta orthopaedica, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
1 citing paper in PubMed.
- Clinical Evidence and FDA Recalls of Artificial Intelligence-Enabled Medical Devices.JAMA network open · 2026Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
background and purposeThe safety and performance of hip and knee prostheses can be assessed by analyzing peer-reviewed literature, registry reports, and safety notices published by national competent authorities/regulatory agencies, or manufacturers. The percentage of hip and knee prostheses with a safety signal published through any of these data sources is unknown. We aimed to assess the frequency of signals identified for a random sample of 10 hip stems, 10 hip cups, and 10 knee implants.
methods3 literature libraries were searched to find safety signals defined as information on patterns/occurrences that may alter the device's benefit-risk profile, reported in peer-reviewed publications for the randomly selected implants. Annual registry reports from 5 national registries were examined to check whether any of the selected implants had outlier performance. The CORE-MD post-market surveillance (PMS) tool was used to collect all related safety notices from 13 competent authority/regulatory agency websites. Manufacturers' websites were screened for any reported safety information.
resultsSafety signals were identified for 21 of the 30 randomly selected implants: 18 identified by registries, 7 by the CORE-MD PMS tool, and 8 based on literature, with 10 implants identified by multiple sources. There was no systematic pattern in timing of publication with a particular source publishing safety signals earlier than other sources.
conclusion70% of the randomly selected hip and knee prostheses had ≥ 1 safety signals published, with registries as the source for the majority. No single source identified all 21 implants with signals, which highlights the need for a comprehensive surveillance strategy to aggregate safety signals from multiple sources.
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