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Ann Alriksson-Schmidt Lund University, Department of Clinical Sciences, Sweden

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Jonas Ranstam Mdas AB, Sweden

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Otto Robertsson Lund University, Department of Clinical Sciences, Sweden

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Lars Lidgren Lund University, Department of Clinical Sciences, Sweden

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Introduction In the wake of the Poly Implant Prosthèse breast implant and the metal-on-metal incidents, the inherent flaws of European regulatory systems for medical products and devices have been highlighted once again. 1 In lieu of the

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Giorgio Perino Department of Orthopedics and Orthopedic Surgery, University Medicine Greifswald, Greifswald, Germany

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Ivan De Martino Division of Orthopaedics and Traumatology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy

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Lingxin Zhang Department of Pathology and Laboratory Medicine, Sinai Health System, Toronto, Canada

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Zhidao Xia Centre for Nanohealth, Swansea University Medical School, Singleton Park, Swansea, UK

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Jiri Gallo Department of Orthopaedics, Faculty of Medicine and Dentistry, University Hospital, Palacky University Olomouc, Czech Republic

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Shonali Natu Department of Pathology, University Hospital of North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees, UK

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David Langton Orthopaedic Department, Freeman Hospital, Newcastle upon Tyne, UK

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Monika Huber Pathologisch-bakteriologisches Institut, Otto Wagner Spital, Wien, Austria

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Anastasia Rakow Department of Orthopedics and Orthopedic Surgery, University Medicine Greifswald, Greifswald, Germany

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Janosch Schoon Department of Orthopedics and Orthopedic Surgery, University Medicine Greifswald, Greifswald, Germany

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Enrique Gomez-Barrena Servicio de Cirugía Ortopédica y Traumatología, Hospital Universitario La Paz-IdiPAZ, Universidad Autónoma de Madrid, Madrid, Spain

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Veit Krenn MVZ-Zentrum für Histologie, Zytologie und Molekulare Diagnostik-GmbH, Trier, Germany

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lymphocytic-dominated vasculitis associated lesion (ALVAL), 20 later expanded to adverse local tissue reactions (ALTR) 21 and adverse reactions to metal debris (ARMD) 22 associated with metal-on-metal (MoM) hip resurfacing arthroplasty (HRA) and

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Richard N. de Steiger Australian Orthopaedic Association National Joint Replacement Registry, SAHMRI, Adelaide, Australia
School of Public Health, Faculty of Health and Medical Sciences, University of Adelaide, Australia

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Stephen E. Graves School of Public Health, Faculty of Health and Medical Sciences, University of Adelaide, Australia

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. Fig. 1 Funnel plot of primary total conventional hip replacement (excluding large-head metal-on-metal, all diagnoses, revision for prosthesis dislocation within 2 years). The Australian Orthopaedic Association has recommended access of a

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Christoph H. Lohmann Department of Orthopeadic Surgery, Otto-von-Guericke University, Leipziger Str. 44,39120 Magdeburg, Germany

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Sanjiv Rampal Department of Orthopeadic Surgery, Otto-von-Guericke University, Leipziger Str. 44,39120 Magdeburg, Germany

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Martin Lohrengel Department of Orthopeadic Surgery, Otto-von-Guericke University, Leipziger Str. 44,39120 Magdeburg, Germany

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Gurpal Singh Division of Musculoskeletal Oncology, University Orthopaedics Hand and Reconstructive Microsurgery Cluster, National University Health System, 1E Kent Ridge Road, 119228 Singapore

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loosening? According to the recommendations provided by the multidisciplinary consensus statement on the use and monitoring of metal-on-metal (MoM) bearings for THA and hip resurfacing, radiographs should be performed in all patients during follow

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Andrew Carr Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

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’ surfaces, there would be a reduction in the risk of dislocation which would be particularly advantageous in younger patients. Unfortunately, this new concept and design was not rigorously tested prior to widespread adoption and use. One particular metal-on-metal

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Georgios Tsikandylakis Department of Orthopaedics, Sahlgrenska University Hospital, Gothenburg, Sweden
Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden
Swedish Hip Arthroplasty Register, Gothenburg, Sweden

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Maziar Mohaddes Department of Orthopaedics, Sahlgrenska University Hospital, Gothenburg, Sweden
Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden
Swedish Hip Arthroplasty Register, Gothenburg, Sweden

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Peter Cnudde Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden
Swedish Hip Arthroplasty Register, Gothenburg, Sweden
Department of Orthopaedics, Prince Philip Hospital, HDUHB, Wales

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Antti Eskelinen Coxa Hospital for Joint Replacement, Tampere, Finland
Finnish Arthroplasty Register, Helsinki, Finland

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Johan Kärrholm Department of Orthopaedics, Sahlgrenska University Hospital, Gothenburg, Sweden
Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden
Swedish Hip Arthroplasty Register, Gothenburg, Sweden

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Ola Rolfson Department of Orthopaedics, Sahlgrenska University Hospital, Gothenburg, Sweden
Department of Orthopaedics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden
Swedish Hip Arthroplasty Register, Gothenburg, Sweden

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groin pain. We excluded hip arthroplasties with metal-on-metal (MoM) bearings due to a limited number of MoMs being used lately ( Fig. 2 ). We also excluded dual mobility acetabular components since this bearing concept is predominantly used in patients

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Jonathan M. R. French Bristol Royal Infirmary, University Hospitals Bristol NHS Trust, Bristol, UK

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Paul Bramley Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK

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Sean Scattergood Bristol Royal Infirmary, University Hospitals Bristol NHS Trust, Bristol, UK

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Nemandra A. Sandiford Southland Teaching Hospital, Invercargill, New Zealand

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, raised serum metal ion levels, magnetic resonance imaging (MRI), and ultimately intraoperative and histological findings. ARMD was first noted in metal-on-metal (MoM) THR, occurring between bearing surfaces and also as a result of fretting corrosion at

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Anna Bogdanova-Bennett Academic Surgical Unit, South West London Elective Orthopaedic Centre, Epsom, UK

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Amit Sagi Academic Surgical Unit, South West London Elective Orthopaedic Centre, Epsom, UK

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Vipin Asopa Academic Surgical Unit, South West London Elective Orthopaedic Centre, Epsom, UK

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Richard E. Field Academic Surgical Unit, South West London Elective Orthopaedic Centre, Epsom, UK

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David H. Sochart Academic Surgical Unit, South West London Elective Orthopaedic Centre, Epsom, UK

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reactions; Co, cobalt; COC, ceramic-on-ceramic; COP, ceramic-on-plastic; Cr, chromium; Fe, iron; Mn, manganese; Mo, molybdenum; MOM, metal-on-metal; MOP, metal-on-plastic; Ni, nickel; NR, not recorded; THR, total hip replacement; Ti, titanium; TJR, total

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M M Morlock Institute of Biomechanics, TUHH Hamburg University of Technology, Hamburg, Germany

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E Gomez-Barrena Department of Orthopaedic Surgery and Traumatology, Universidad Autónoma de Madrid, Madrid, Spain

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D C Wirtz Department of Orthopaedics and Traumatology, University Hospital Bonn, Bonn, Germany

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A Hart London Implant Retrieval Centre, Royal National Orthopaedic Hospital, Stanmore, UK

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J P Kretzer Department of Orthopaedic Surgery, Heidelberg University Hospital, Heidelberg, Germany

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( 5 ), wear problems with highly crystalline phase-modified polyethylene ( 6 ) and toxicological surface contamination on porous-coated sockets ( 7 ). Innovative procedures such as hip resurfacing and large metal-on-metal hip joint bearings ( 8 ) ( Fig

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Luigi Zagra Hip Department, IRCCS Istituto Ortopedico Galeazzi, Milan Italy

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that “we should offer effective treatment based on the best available evidence”. 7 Anyway the lesson learnt by the metal-on-metal THA experience have made all the stakeholders more careful in the introduction of hip implants onto the market and

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