Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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This field safety notice is to provide information on the use of the revitan revision system and is jointly provided with the latest updated surgical techniques with references 06.01169.012 and 06.01109.012. zimmer gmbh would like to emphasize that patient selection for modular hip revision systems such as the revitan system is a key parameter. modular stems have been used in revision surgery for many years and provide advantages for issues that are frequently encountered in a revision setting. however a modular system also comes with the risk for potential stem fractures. this is a rare complication of modular revision stems caused most commonly by large stresses to the modular junction when the proximal component lacks medial bone contact at the calcar.45 the risk of stem failure is not unique to any one modular system. bone stock of adequate quality must be present and appraised at the time of surgery. for patients with severe proximal deficiency a surgeon should consider surgical options to ensure proximal bone support (such as medial and/or lateral strut grafts) or switching to a monobloc revision stem such as the wagner sl revision hip stem. please review the indications and contra indications in the associated surgical techniques and instructions for use of the revitan revision system.
“The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.