DePuy May Not Escape From A Pinnacle Hip Replacement Recall
From its humble beginnings as a splint manufacturing company in the late 1800s, DePuy’s founding fathers could not have realized that the company would one day become a dominant industry leader. After Johnson & Johnson acquired the company in 1998, DePuy was nothing less than a major asset by earning $5 billion in annual revenue from sales of its medical devices. The company has fallen on some hard times over the last few months with the recall of its ASR hip replacement system and a possible DePuy Pinnacle recall stemming from reports that these metal-on-metal devices have increasing failure rates among its recipients. All DePuy can do is wait for the wave of litigation that is surely imminent.
The U.S. Food and Drug Administration (FDA) is responsible for allowing the marketing of the DePuy ASR system to the consumer through its 510(k) approval process. According to this process, the FDA approves the marketing of a medical device on the condition that the company can prove that the device is “substantially equivalent” to another device already approved and on the market. Many concerns were raised because the ASR system avoided necessary clinical trials by showing similarities with the approved DePuy Pinnacle system.
Over 500 complaints have subsequently been received by the FDA against the Pinnacle system, mostly because the device is prone to loosen prematurely. More alarming is a recent New York Times report that metal-on-metal devices like Pinnacle carry the increased risk of causing metal toxicity in a recipient. Since the metal components of these devices experience constant friction, metal particles are then released into the soft tissue surrounding tissue and into the bloodstream. Build up of these metallic particles may cause the patient to suffer symptoms of metallosis. Although the symptoms of metallosis vary, patients will typically complain of feelings of disorientation and unexplained depression.
A significant increase in the number of Pinnacle hip replacements recipients suffering from adverse effects also increases the possibility of a DePuy Pinnacle recall. Recipients that are experiencing symptoms of metallosis, or have loosening devices should seek legal consultation. For updated information, visit the DePuy Pinnacle recall website.
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