DePuy Discontinues Metal-on-Metal Implants, Focus on Plastic and Ceramic Systems
Effective August 31, 2013, US headquartered manufacturer of orthopaedic devices DePuy Orthopaedics will discontinue global sales of two brands of hip implant systems—the Ultamet metal-on-metal articulation device and the Complete brand of ceramic-on-metal acetabular hip system. The discontinuation date of August 31, 2013, will allow surgeons to plan accordingly for upcoming surgeries. The ceramic head used in the Complete brand will continue to be available for use in other bearing surface combinations.
The metal liner that is being discontinued is used in both Ultamet and Complete. The liner is designed exclusively for use with DePuy’s Pinnacle Acetabular Cup System, the Pinnacle Cup is not impacted by this discontinuation. The Pinnacle Cup System is one of the most widely used and clinically successful modular acetabular systems for hip replacement and will continue to be offered with both medical grade plastic and ceramic liners.
The decision to discontinue Ultamet and Complete was made in conjunction with an ongoing review of DePuy’s product portfolio. Other worldwide product discontinuations will be announced throughout 2013 and 2014 that will simplify and streamline DePuy’s portfolio by focusing on fewer, worldwide strategic product platforms that meet patient and clinician needs and ensure long-term growth.
DePuy made the decision to discontinue these products because of low clinician use of Ultamet and Complete, the availability of other options that meet the clinical needs of patients, and proposed changes in FDA regulation of the entire class of metal-on-metal products, which includes Ultamet.
Clinician use of ceramic-on-metal and metal-on-metal bearings is extremely low and not expected to increase. In the United States and Europe in 2012, metal-on-metal bearings comprised less than two percent of the bearings implanted.1. This represents a 90% decline in industry sales since 2007. Industry sales of ceramic-on-metal bearings have been low since their introduction to the market. Consistent with this overall market trend, Ultamet and Complete brands now represent less than one percent of DePuy bearings sold in these markets.
Advancements in polyethylene bearing technology and the recent approval of next generation options that meet the clinical needs of patients also contributed to this decision. Physician preferences have shifted toward metal-on-polyethylene, ceramic-on-polyethylene and ceramic-on-ceramic bearings. These options include the newly approved Ceramax Total Hip System with Biolox delta Ceramic-On-Ceramic 36 mm Large Femoral Head for use with the Pinnacle Acetabular Cup System. Physician use of ceramic-on-ceramic (CoC) bearings is widespread in Europe where, in 2012, CoC represented over one in five bearings used.2 CoC bearings also have considerable growth potential in the US where new options are coming to market.
Another factor in the decision to discontinue Ultamet is the proposed regulatory change by the US Food and Drug Administration (FDA), which announced in January that it plans to require all metal-on-metal hip replacements with existing 510(k) clearances to be approved through the Premarket Approval (PMA) process. Ultamet was first cleared for sale through the 510(k) process in 2000. DePuy will continue to invest in new bearing technologies like ceramic and polyethylene technologies. Investing resources to seek and maintain a PMA in low-use brands like Ultamet and Complete does not align with this long-term strategy. DePuy has communicated to the FDA its decision not to pursue a PMA submission for Ultamet.
The decision to discontinue these products is not related to safety or efficacy, and is not a recall. Ultamet and Complete are backed by clinical data showing they are safe and effective options for patients who are candidates for hip replacement. As with all of our products, DePuy will continue to closely monitor the performance of Ultamet and COMPLETE. DePuy reviews performance data from a variety of sources, including published and unpublished data from national joint registries, published literature, company-sponsored clinical trials and internal complaint data. This includes the FDA’s industry wide post-market surveillance of metal-on-metal hip systems.
DePuy is communicating this decision to surgeons, hospitals and other interested parties. Clinicians and patients can learn more by visiting http://www.depuy.com/pinnacleclinical and http://www.depuy.com/pinnaclepatient.
The Ultamet and Complete products include two components used during hip replacement surgery: a cup liner and a femoral head. Both products use the same metal liner, which sits in a metal cup that is placed in the pelvis, but each uses different femoral heads. These heads attach to stems that are inserted into the femur during surgery. Ultamet includes a metal head that rotates inside the metal liner in the pelvis, whereas Complete uses a ceramic head. Only the metal liner used in these products is being discontinued.
DePuy is committed to continuing to provide surgeons the choices and options they need to help patients who are candidates for hip replacement surgery. The Complete Cup System has among the broadest and most advanced options available on the market today and a demonstrated track record of helping to reduce pain and restore mobility for patients suffering from chronic hip pain.
In May 2012 Medical Plastics News reported that the Bioengineering Unit at the University of Strathclyde in Glasgow, UK, had investigated a metal on metal hip implant system. The report is as follows.
May 10, 2012 Following the release of an alert by the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) in September 2010, a DePuy ASR (Articular Surface Replacement) metal hip replacement was withdrawn from the market because of increased incidence of failure. The problem was caused by adverse reactions to wear debris and metal ions released from the implant and the concerns of patients have been well publicised.
Work carried out in the University of Strathclyde's Bioengineering Unit by a group of researchers led by Professor Helen Grant has investigated the mechanisms involved in adverse reactions to the metallic cobalt chromium (CoCr) alloy wear debris generated from the ASR hip joint. This manuscript, published by the UK Scientific Publisher The Royal Society Interface, represents the work of a PhD student, Moeed Akbar, funded by a UK Engineering and Physical Research Council (EPSRC) Case Award with De Puy International Ltd, in collaboration with Professor Jim Brewer and colleagues at Glasgow University.
The work demonstrates an inflammatory reaction in response to implantation of the CoCr wear debris into mice, and shows the presence of necrosis and fibrosis locally in adjacent tissues. Previous work by the group using the same animal model published in the Journal of Biomedical Material Research last month demonstrated the release of metal ions, particularly cobalt, from the wear debris. Cobalt ions disseminated rapidly into the blood, and were measured in organs including the liver, kidney, heart, lungs, spleen, brain and testes. These findings in the in vivo mouse model suggest that encapsulation of the wear debris with inflammatory cells and fibrotic tissue, as well as formation of necrotic tissue and release of cobalt ions into the circulation may contribute to the adverse reactions to metal debris observed in patients.
The manuscript from the Royal Society is as follows:
"Adverse reactions to metal debris generated by metal-on-metal hip resurfacing are thought to be due to an inflammatory process in response to excessive particulate metal debris. To investigate this, the inflammatory response to cobalt chromium alloy (CoCr) wear debris from a metal-on-metal hip resurfacing implant was measured in a rodent air pouch model for up to 7 days. Air-pouches were injected with either sterile phosphate buffered saline, lipopolysaccharide (as positive control) or the CoCr debris. Inflammatory exudates showed that CoCr debris induced a specific inflammatory reaction. Debris accumulated in the pouch wall and this was accompanied by a vast infiltration of inflammatory cells, primarily monocytes/macrophages, as well as fibrosis and tissue necrosis around the debris. The CoCr debris also increased expression of chemokines and cytokines involved in promoting inflammation and fibrosis. Encapsulation of CoCr debris by fibrotic tissue and inflammatory cells may also contribute to the adverse reactions to metal debris seen in patients."
The work by Strathclyde's bioengineering unit demonstrates an inflammatory reaction in response to implantation of the CoCr wear debris into mice, and shows the presence of necrosis and fibrosis locally in adjacent tissues.
Sources:
1. Based on multiple sources including ONN, Industry Surveys and Management Estimates
2. Source: European Markets For Large Joint Reconstructive Implants. Millenium Research Group: March 2013.