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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Ongoing analysis of the global data following the product correction does not yield a significant increase in the global reported rate for adverse local tissue reaction (altr).However the additional data which includes variability in altr rates among sites may potentially be predictive of an increased likelihood of this condition for both the rejuvenate and abg ii modular hip systems. based on information received to date a product field action to remove these products is being conducted.