Safety notices and registry outlier data measure different aspects of safety and performance of total knee implants: a comparative study of safety notices and register outliers
55% of the TKA with a safety notice were identified as outliers in the registry, whereas around 25% of TKA outliers are not the subject of publicly released safety notices, with safety notices pointing to TKA implants not identified by registries as potentially having a higher risk of failure. This suggests that safety notices and registry outlier data measure different aspects of safety and performance.
Authors
- Robert E. Geertsma (ORCID: https://orcid.org/0000-0003-0979-9077)
- Lotje A. Hoogervorst (ORCID: https://orcid.org/0000-0001-5343-6965)
- Enrico G. Caiani (ORCID: https://orcid.org/0000-0002-1770-6486)
- Rob G. H. H. Nelissen (ORCID: https://orcid.org/0000-0003-1228-4162)
- Perla J. Marang‐van de Mheen (ORCID: https://orcid.org/0000-0003-1439-0989)
- Alan G. Fraser (ORCID: https://orcid.org/0000-0001-7083-6995)
- Yijun Ren (ORCID: https://orcid.org/0000-0001-5361-2447)
- Ashley A. Stratton‐Powell (ORCID: https://orcid.org/0000-0002-1390-2789)
- Anne Lübbeke (ORCID: https://orcid.org/0000-0002-6905-6120)
- Tom Melvin (ORCID: https://orcid.org/0000-0001-6370-4177)
Institutions
- University of Geneva (CH)
- Trinity College Dublin (IE)
- Leiden University Medical Center (NL)
- University Hospital of Wales (GB)
- Nuffield Orthopaedic Centre (GB)
- University of Oxford (GB)
- National Institute for Public Health and the Environment (NL)
- University Hospital of Geneva (CH)
- IRCCS Istituto Auxologico Italiano (IT)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
- Geneva College (US)
- Politecnico di Milano (IT)
- Delft University of Technology (NL)
Publication Details
- Journal
- Acta Orthopaedica
- Published
- 2024-11-25
- DOI
- https://doi.org/10.2340/17453674.2024.42361
- Citations
- 2
- Primary Topic
- Safety Systems Engineering in Autonomy
- Type
- article
- Field-Weighted Citation Impact
- 0.73