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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| Format: | Article |
| Language: | English |
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Medical Journals Sweden
2025-06-01
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| Series: | Acta Orthopaedica |
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| Online Access: | https://actaorthop.org/actao/article/view/44035 |
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| author | Yijun Ren Lotje A Hoogervorst Enrico G Caiani Perla J Marang-van de Mheen James A Smith Alan G Fraser Rob G H H Nelissen Anne Lübbeke |
| author_facet | Yijun Ren Lotje A Hoogervorst Enrico G Caiani Perla J Marang-van de Mheen James A Smith Alan G Fraser Rob G H H Nelissen Anne Lübbeke |
| author_sort | Yijun Ren |
| collection | DOAJ |
| description |
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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| format | Article |
| id | doaj-art-16909dc9c4da4d35a9a9f1f6e46546a0 |
| institution | Kabale University |
| issn | 1745-3674 1745-3682 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Medical Journals Sweden |
| record_format | Article |
| series | Acta Orthopaedica |
| spelling | doaj-art-16909dc9c4da4d35a9a9f1f6e46546a02025-08-20T03:32:15ZengMedical Journals SwedenActa Orthopaedica1745-36741745-36822025-06-019610.2340/17453674.2025.44035Frequency of safety signals from scientific reports, manufactures, registers, and other sources for a random selection of hip and knee prosthesesYijun Ren0https://orcid.org/0000-0001-5361-2447Lotje A Hoogervorst1https://orcid.org/0000-0001-5343-6965Enrico G Caiani2Perla J Marang-van de Mheen3James A Smith4Alan G Fraser5Rob G H H Nelissen6https://orcid.org/0000-0003-1228-4162Anne Lübbeke7https://orcid.org/0000-0002-6905-6120Department of Electronics, Information and Biomedical Engineering, Politecnico di Milano, Milan, ItalyDDepartment of Orthopaedics, Leiden University Medical Center, Leiden, the NetherlandsDepartment of Electronics, Information and Biomedical Engineering, Politecnico di Milano, Milan, Istituto Auxologico Italiano IRCCS, Milan, Italy Department of Orthopaedics, Leiden University Medical Center, Leiden; Safety & Security Science and Centre for Safety in Healthcare, Delft University of Technology, Delft, the NetherlandsBotnar Research Centre and Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford; 6 National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UKDepartment of Cardiology, University Hospital of Wales, Heath Park, Cardiff, UKDepartment of Orthopaedics, Leiden University Medical Center, Leiden, the NetherlandsDivision of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Geneva, Switzerland; 9 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK 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. https://actaorthop.org/actao/article/view/44035Arthroplasty registriesHipKneeReal-world dataSafety noticesSafety signals |
| spellingShingle | Yijun Ren Lotje A Hoogervorst Enrico G Caiani Perla J Marang-van de Mheen James A Smith Alan G Fraser Rob G H H Nelissen Anne Lübbeke Frequency of safety signals from scientific reports, manufactures, registers, and other sources for a random selection of hip and knee prostheses Acta Orthopaedica Arthroplasty registries Hip Knee Real-world data Safety notices Safety signals |
| title | Frequency of safety signals from scientific reports, manufactures, registers, and other sources for a random selection of hip and knee prostheses |
| title_full | Frequency of safety signals from scientific reports, manufactures, registers, and other sources for a random selection of hip and knee prostheses |
| title_fullStr | Frequency of safety signals from scientific reports, manufactures, registers, and other sources for a random selection of hip and knee prostheses |
| title_full_unstemmed | Frequency of safety signals from scientific reports, manufactures, registers, and other sources for a random selection of hip and knee prostheses |
| title_short | Frequency of safety signals from scientific reports, manufactures, registers, and other sources for a random selection of hip and knee prostheses |
| title_sort | frequency of safety signals from scientific reports manufactures registers and other sources for a random selection of hip and knee prostheses |
| topic | Arthroplasty registries Hip Knee Real-world data Safety notices Safety signals |
| url | https://actaorthop.org/actao/article/view/44035 |
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