Richard N de Steiger
Richard N de Steiger
Australian Orthopaedic Association National Joint Replacement Registry, SAHMRI, Adelaide, Australia
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Brian R Hallstrom
Brian R Hallstrom
Michigan Arthroplasty Registry Collaborative Quality Initiative University of Michigan, Department of Orthopaedic Surgery, Ann Arbor, Michigan, USA
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Anne Lübbeke
Anne Lübbeke
Geneva Arthroplasty Registry, Geneva University Hospitals Rue Gabrielle-Perret-Gentil 4 CH-1211 Geneva, Switzerland
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Elizabeth W Paxton
Elizabeth W Paxton
Surgical Outcomes and Analysis Unit, Kaiser Permanente National Implant Registries 8954 Rio San Diego Drive, Suite, San Diego, California, USA
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Liza N van Steenbergen
Liza N van Steenbergen
Dutch Arthroplasty Register (Landelijke Registratie Orthopedische Implantaten (LROI)), Bruistensingel 230 | 5232 AD ’s-Hertogenbosch, The Netherlands
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Mark Wilkinson
Mark Wilkinson
Department of Oncology and Metabolism, University of Sheffield, Beech Hill Road, Sheffield, United Kingdom
National Joint Replacement for England, Wales, Northern Ireland, Isle of Man and the States of Guernsey (NJR)
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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withdrawn worldwide in 2010.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
M M Morlock
M M Morlock
Institute of Biomechanics, TUHH Hamburg University of Technology, Hamburg, Germany
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E Gomez-Barrena
E Gomez-Barrena
Department of Orthopaedic Surgery and Traumatology, Universidad Autónoma de Madrid, Madrid, Spain
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D C Wirtz
D C Wirtz
Department of Orthopaedics and Traumatology, University Hospital Bonn, Bonn, Germany
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A Hart
A Hart
London Implant Retrieval Centre, Royal National Orthopaedic Hospital, Stanmore, UK
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J P Kretzer
J P Kretzer
Department of Orthopaedic Surgery, Heidelberg University Hospital, Heidelberg, Germany
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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
Claus Varnum
Claus Varnum
The Danish Hip Arthroplasty Register
Department of Orthopaedic Surgery, Vejle Hospital, Vejle, Denmark
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Department of Orthopaedic Surgery, Vejle Hospital, Vejle, Denmark
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Alma Bečić Pedersen
Alma Bečić Pedersen
Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark
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Ola Rolfson
Ola Rolfson
The Swedish Hip Arthroplasty Register
Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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Cecilia Rogmark
Cecilia Rogmark
The Swedish Hip Arthroplasty Register
Lund University, Skåne University Hospital, Department of Orthopedics, Malmö, Sweden
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Lund University, Skåne University Hospital, Department of Orthopedics, Malmö, Sweden
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Ove Furnes
Ove Furnes
The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway
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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Geir Hallan
Geir Hallan
The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway
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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Keijo Mäkelä
Keijo Mäkelä
The Finnish Arthroplasty Register
Department of Orthopaedics and Traumatology, Turku University Hospital, Turku, Finland
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Department of Orthopaedics and Traumatology, Turku University Hospital, Turku, Finland
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Richard de Steiger
Richard de Steiger
Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), Adelaide, Australia
Department of Surgery, Epworth HealthCare, University of Melbourne, Melbourne, Australia
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Department of Surgery, Epworth HealthCare, University of Melbourne, Melbourne, Australia
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Martyn Porter
Martyn Porter
The National Joint Registry of England, Wales, Northern Ireland and Isle of Man
Centre for Hip Surgery, Wrightington Hospital, Wrightington, Wigan and Leigh NHS Trust, Lancashire, United Kingdom
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Centre for Hip Surgery, Wrightington Hospital, Wrightington, Wigan and Leigh NHS Trust, Lancashire, United Kingdom
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Søren Overgaard
Søren Overgaard
The Danish Hip Arthroplasty Register
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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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
Tom Melvin
Tom Melvin
Medical Officer, Health Products Regulatory Authority, Dublin, Republic of Ireland
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Marina Torre
Marina Torre
Engineer, Senior Researcher, Istituto Superiore di Sanità, Rome, Italy
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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
Ann Alriksson-Schmidt
Ann Alriksson-Schmidt
Lund University, Department of Clinical Sciences, Sweden
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Jonas Ranstam
Jonas Ranstam
Mdas AB, Sweden
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Otto Robertsson
Otto Robertsson
Lund University, Department of Clinical Sciences, Sweden
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Lars Lidgren
Lars Lidgren
Lund University, Department of Clinical Sciences, Sweden
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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
Anne Lübbeke
Anne Lübbeke
Division of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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Christophe Combescure
Christophe Combescure
Division of Clinical Epidemiology, Geneva University Hospitals and University of Geneva, Switzerland
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Christophe Barea
Christophe Barea
Division of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
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Amanda Inez Gonzalez
Amanda Inez Gonzalez
Division of Orthopaedic Surgery & Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
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Keith Tucker
Keith Tucker
Chair Orthopaedic Data Evaluation Panel, UK
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Per Kjærsgaard-Andersen
Per Kjærsgaard-Andersen
Center for Adult Hip and Knee Reconstruction, Department of Orthopaedics, South Danish University, Vejle Hospital, Denmark
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Tom Melvin
Tom Melvin
School of Medicine, Trinity College Dublin, Ireland
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Alan G Fraser
Alan G Fraser
Department of Cardiology, University Hospital of Wales, Cardiff, UK
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Rob Nelissen
Rob Nelissen
Department of Orthopaedics, Leiden University Medical Center, Leiden, The Netherlands
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James A Smith
James A Smith
Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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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. 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
Andrew Carr
Andrew Carr
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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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
Anne Lübbeke
Anne Lübbeke
Division of Orthopaedic Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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James A. Smith
James A. Smith
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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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Daniel Prieto-Alhambra
Daniel Prieto-Alhambra
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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Andrew J. Carr
Andrew J. Carr
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
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
Alan G. Fraser
Alan G. Fraser
Department of Cardiology, University Hospital of Wales, Cardiff, UK
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Rob G.H.H. Nelissen
Rob G.H.H. Nelissen
Department of Orthopaedics, Leiden University Medical Center, Leiden, Netherlands
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Per Kjærsgaard-Andersen
Per Kjærsgaard-Andersen
Department of Orthopaedics, Vejle Hospital, South Danish University, Vejle, Denmark
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Piotr Szymański
Piotr Szymański
Centre of Postgraduate Medical Education, MSWiA Central Clinical Hospital, Warsaw, Poland
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Tom Melvin
Tom Melvin
Healthcare Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Ireland
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Paul Piscoi
Paul Piscoi
Health Technology Unit B6, Directorate General for Health (DG SANTE), European Commission, Brussels, Belgium
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On behalf of the CORE–MD Investigators (see Appendix)
On behalf of the CORE–MD Investigators (see Appendix)
Alan Fraser, Piotr Szymański, Chris Gale, Aldo Maggioni, Elisabetta Zanon, Christina Dimopoulou, Cinzia Ceccarelli, Polyxeni Vairami, Anett Ruszanov, Per Kjærsgaard-Andersen, Rob Nelissen, Adrian Ott, Elizabeth Macintyre, Loredana Simulescu, Marieke Meijer, Berthold Koletzko, Sarah Wieczorek, Adamos Hadjipanayis, Stefano Del Torso, Perla Marang-van de Mheen, Lotje Hoogervorst, Ewout W. Steyerberg, Bas Penning De Vries, Peter McCulloch, Martin Landray, Daniel Prieto Alhambra, James Smith, Anne Lubbeke-Wolf, Stefan James, Sergio Buccheri, Robert Byrne, Laurna McGovern, Stephan Windecker, Andre Frenk, Georgios Siontis, Christoph Stettler, Arjola Bano, Lia Bally, Frank E. Rademakers, Jan D‘hooge, Anton Vedder, Elisabetta Biasin, Erik Kamenjasevic, Petra Schnell-Inderst, Felicitas Kühne, Ola Rolfson, Joel Jakobsson, Amanda Tornsö, Enrico G. Caiani, Lorenzo Gianquintieri, Cinzia Cappiello, Maristella Matera, Tom Melvin, Niall MacAleenan, Ria Mahon, Michèle Meagher, Gearóid McGauran, Thomas Wejs Møller, Ann-Sofie Sonne Holm-Schou, Jan Szulc, Robert E. Geertsma, Jantine W.P.M. van Baal, Joëlle M. Hoebert, Susana L.F. Cabaço, Paola Laricchiuta, Marina Torre, Filippo Boniforti, Eugenio Carrani, Stefania Ceccarelli, Claudia Wild, Sabine Ettinger, Juan Antonio Blasco Amaro, Juan Carlos Rejón Parrilla, Agnieszka Dobrzynska, David Epstein, Valentina Strammiello, Hannes Jarke, Kaisa Immonen, Françoise Schlemmer, Sabina Hoekstra, Marianna Mastroroberto, Christoph Ziskoven, Michael Hahn, Erman Melikyan, Richard Holborow, Suzanne Halliday, Alexey Shiryaev, Gero Viola, Harry van Vugt
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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
Søren Overgaard
Søren Overgaard
Department of Orthopaedic Surgery and Traumatology, Copenhagen University Hospital, Copenhagen, Denmark
Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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Department of Clinical Medicine, Faculty of Health & Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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Thomas M Grupp
Thomas M Grupp
Aesculap AG Research & Development & Medical Scientific Affairs, Tuttlingen, Germany
Department of Orthopaedic and Trauma Surgery, Ludwig Maximilians University Munich, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, Germany
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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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Rob GHH Nelissen
Rob GHH Nelissen
Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands
Technical University Delft, Delft, the Netherlands
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Technical University Delft, Delft, the Netherlands
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Luca Cristofolini
Luca Cristofolini
Department of Industrial Engineering, School of Engineering and Architecture, Alma Mater Studiorum - Università di Bologna, Bologna, Italy
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Anne Lübbeke
Anne Lübbeke
Division of Surgery and Traumatology, Geneva University Hospitals and University of Geneva, Switzerland
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK
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Marcus Jäger
Marcus Jäger
Department of Orthopaedics, Trauma & Reconstructive Surgery St. Marien Hospital Mülheim an der Ruhr & Chair of Orthopaedics and Trauma Surgery University of Duisburg–Essen, Essen, Germany
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Matthias Fink
Matthias Fink
TÜV Süd Product Service GmbH, Clinical Centre of Excellence, Munich Germany
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Sabine Rusch
Sabine Rusch
Aesculap AG Research & Development & Medical Scientific Affairs, Tuttlingen, Germany
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Hassan Achakri
Hassan Achakri
Zimmer Biomet, Clinical, Regulatory & Quality Affairs, Winterthur, Switzerland
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Francesco Benazzo
Francesco Benazzo
IUSS Pavia, Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy
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Dario Bergadano
Dario Bergadano
Medacta International SA, Medical Affairs, Castel San Pietro, Switzerland
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Georg N Duda
Georg N Duda
Julius Wolff Institute and Center for Muskuloskeletal Surgery, Berlin Institute of Health at Charité Universitätsmedizin Berlin, Germany
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Christian Kaddick
Christian Kaddick
EndoLab Mechanical Engineering GmbH, Riedering, Germany
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Volkmar Jansson
Volkmar Jansson
Department of Orthopaedic and Trauma Surgery, Ludwig Maximilians University Munich, Musculoskeletal University Center Munich (MUM), Campus Grosshadern, Munich, Germany
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Klaus-Peter Günther
Klaus-Peter Günther
University Clinic Carl Gustav Carus, Center for Orthopaedic & Trauma Surgery, Technical University Dresden, Dresden, Germany
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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
