The Concerns Associated With The Depuy Pinnacle Hip Replacement System

From its humble beginnings as a splint manufacturing company in the late 1800s

, DePuys founding fathers could not have realized that the company would one day become a dominant industry leader. More people who experience symptoms of metallosis and hip pain, or have loosening devices are seeking legal consultation and compensation. An all metal hip replacement research has been coordinated by a group because of these rising issues.

The loophole in the approval process of these malfunctioning devices was seen as a major cause why numerous lawsuits are happening. Through its 510(k) approval process, the U.S. Food and Drug Administration allowed the DePuy Pinnacle system to be marketed publicly. The sale and distribution of a medical device can go without subjecting to necessary clinical trials as long as the manufacturer can show the FDA that the device is substantially equivalent to the safety level of a similar device already approved on the market. The similarity of other hip replacement system with the Pinnacle system currently on the market was one of the bases why this particular hip device was approved. Due to its inherent risks, a number of groups are condemning the Pinnacle system.

The FDA has reported over 500 complaints being made against the Pinnacle system. While most of these complaints zeroed in on the device loosening prematurely, a report published in 2010 has focused on the serious risk of metal toxicity. Increasing the risk of metal toxicity due to the friction of their metal components causing release of metal particles into the bloodstream has been evident on metal-on-metal devices like the Pinnacle system which is in contrast with the typical hip replacement system that uses a synthetic plastic liner inside the socket component of the synthetic joint. With the buildup of these metallic particles, patients may suffer symptoms of metallosis, which include disorientation and feelings of general malaise.

Back in the late 1800s when DePuy was formed as a splint manufacturing company, its founders could never have imagined that it would become the industry leader it is today. Since Johnson & Johnson purchased the company in 1998, the investment in DePuy has paid dividends, bringing $5 billion in annual sales revenue from its medical devices. The company has suffered some setbacks in the recent months. The company has been facing complaints with their ASR hip system resulting to litigations and a recall. Now, a DePuy Pinnacle hip replacement lawsuit is being filed by a lot of people which is another challenge for the company to face.

by: Gregory Fraser

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