Frequency of safety signals from scientific reports, manufactures, registers, and other sources for a random selection of hip and knee prostheses
Background and purpose: The 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...
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| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Medical Journals Sweden
2025-06-01
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| Series: | Acta Orthopaedica |
| Subjects: | |
| Online Access: | https://actaorthop.org/actao/article/view/44035 |
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| Summary: | Background and purpose: The 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.
Methods: 3 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.
Results: Safety 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.
Conclusion: 70% 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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| ISSN: | 1745-3674 1745-3682 |