The DePuy ASR Acetabular Cup System first came on the market in 2005. It was cleared by the U.S. Food & Drug Administration (FDA) via a process known as 510(k) approval. This process allows a manufacturer to obtain market approval with very little clinical testing of the device - including no human testing - if a manufacturer can prove it is "substantially similar" to another product already on the market. In 2010, an internal FDA review - ironically released shortly after the DePuy ASR hip implant recall was issued - found numerous flaws with the 510(k) process, prompting the agency to consider changing it.
In August 2010, DePuy issued a worldwide recall for the ASR XL Acetabular Hip Replacement System after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. By then, more than 93,000 patients worldwide were fitted with an ASR hip implant. It is believed that roughly a third of those were patients in the U.S. In its second-quarter earnings results, Johnson & Johnson, DePuy’s parent company, reported that it paid $223 million in connection with DePuy ASR hip replacement recalls, litigation associated with the defective hip implant and other products.
In addition to a mounting number of DePuy ASR lawsuits filed in recent months over their recalled metal-on-metal hip replacement, DePuy Orthopedics is now facing lawsuits over their DePuy Pinnacle metal-on-metal hip replacement. According to the U.S. Food & Drug Administration (FDA), because the metal ball and the metal cup on these types of hip implants slide against each other during walking or running, some tiny metal particles may wear off of the device and enter into the space around the implant. Some of the metal ions from the metal implant or from the metal particles may even get into the bloodstream. It is known that over time, the metal particles around some implants can cause damage to bone and/or tissue surrounding the implant and joint.
The figures just reflect the quality of the company itself. asr recall
ReplyDeleteI guess it is just so frustrating being included in this depuy hip recall.
ReplyDeleteWell I guess these depuy hip recall lawyer are on.
ReplyDeleteBecause of the recalled hip replacement, many have decided to file for depuy hip lawsuit.
ReplyDeleteThe only thing protecting these patients from the incompetent medical industries are lawyers even if we know that it will take a lot more than DePuy Pinnacle lawsuits to stop them. The big sums of money paid out in lawsuits by the medical industries are very tiny compared to their profit. If every lawyer in the United States became a service liability and medical product lawyers there still would not be enough lawyers to serve the thousands of victims each year. These medical industries in the US is over 20% of the UD GDP making it the 4th or 5th largest economy in the world.
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