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DePuy May Have Known About ASR’s Problems In 2007
Posted on June 6, 2011 by Rottenstein Law Group, Source – click here
It appears that DePuy could foresee the problems that were going to occur with regard to its ASR acetabular cup system long before the August 2010 recall of the device. On October 29, 2007, DePuy presented a slight change to its ASR system, which had initially been approved by the U.S. Food and Drug Administration (FDA) two years prior. Three spikes were added to the outer surface of the cup component of the hip replacement system for the purpose of “adjunct fixation.” This modification, much like the original ASR design, was granted FDA approval through the controversial 510(k) approval process, which requires no pre-market testing.
According to the Section 510(k) summary, the new design is “identical in design to the acetabular cups cleared as part of the DePuy ASR Modular Acetabular Cup System in K040627 on August 5, 2005 with the addition of spikes on the outer surface of the cup.” This indicates that for whatever reason, two years after the product was approved and released for sale, DePuy felt it necessary to add an additional measure to help the product fix itself to the bone. Given the high rate of failure that would come to light just a couple years later, one cannot help but question whether the company went far enough in remedying the problems with the device that were likely apparent at the time.
This is yet another condemnation of the Section 510(k) approval process. Companies like DePuy who release badly designed or harmful products have an avenue to make an attempt to put a band-aid on a product that should really be recalled. It is the near 50% of patients that received the ASR hip replacement device and suffered a failure within just a few years that have to suffer as a result.
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