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National Joint Replacement for England, Wales, Northern Ireland, Isle of Man and the States of Guernsey (NJR)
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withdrawn worldwide in 2010. This resulted in tighter regulations regarding the introduction of monitoring for new implants ( 13 ) demonstrating the critical role of registries in post-market total joint replacement surveillance. While many joint
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Directive issued in 1993. The MDR requires post-market surveillance of all class IIb and III products by the manufacturers, who have to demonstrate the clinical safety of their products on a yearly basis. This will provide a substantially higher level of
Department of Orthopaedic Surgery, Vejle Hospital, Vejle, Denmark
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Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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Lund University, Skåne University Hospital, Department of Orthopedics, Malmö, Sweden
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Department of Clinical Medicine, University of Bergen, Bergen, Norway
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Department of Clinical Medicine, University of Bergen, Bergen, Norway
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Department of Orthopaedics and Traumatology, Turku University Hospital, Turku, Finland
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Department of Surgery, Epworth HealthCare, University of Melbourne, Melbourne, Australia
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Centre for Hip Surgery, Wrightington Hospital, Wrightington, Wigan and Leigh NHS Trust, Lancashire, United Kingdom
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Orthopaedic Research Unit, Department of Clinical Research, University of Southern Denmark, Odense, Denmark
Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Odense, Denmark
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recognized that enhanced post-market surveillance would be useful and an initiative called ‘Beyond Compliance’ was introduced in 2012. 58 It was named Beyond Compliance because this was voluntary and beyond the European regulatory requirements. The NJR
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to their device. The clinical evaluation then informs the extent to which the device manufacturer is required to further examine their device once made available on the market, by means of post-market surveillance (PMS) or post-market clinical follow
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being introduced on the market. Despite this, of these 70 devices, 12 were subsequently subjected to FDA recalls during their lifespans, and no less than 765 post-market modifications were recorded. 3 Twenty-two percent of these post-market
Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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. Under the MDR, post-market surveillance is expected to be proactive and continuous, with clinically meaningful comparator(s) and clinically relevant endpoints (risks and benefits). The evidence identified in this review would often not have met those
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the increased use of post-market surveillance and intends to fortify the 510(k) system. This falls significantly short of the Institute of Medicine’s recommendation to eliminate the 510(k) route. The US system will improve device recall and will
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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National Institute for Health Research Oxford Biomedical Research Centre, John Radcliffe Hospital, Oxford, UK
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difficult to bridge the gap between pre- and post-market assessment and to identify the extent and importance of treatment with implantable devices in the healthcare sector and the problems associated with it. Fragmentation may thus also be one of the
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important difference; and what follow-up intervals would be recommended for assessing PROMs for specific interventions. A systematic review will assess how PROMs have been used in trials and studies for regulatory purposes and post-market surveillance, and
Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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Department of Orthopaedic and Trauma Surgery, Ludwig Maximilians University Munich, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, Germany
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Technical University Delft, Delft, the Netherlands
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Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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unexpected detected failures. Detected failure modes Typical scenarios (exemplary) Early failure modes in pre‐market setting Fatigue failure of implants Liner wear Late failures in the post‐market setting Excessive