In August of 2010, the U.S. Food and Drug Administration (FDA) ordered a recall of DePuy’s ASR hip replacement systems. The recall was due to a much higher than industry-accepted estimated failure rate of 12% within five years of the initial replacement surgery. Since their introduction in 2003, the ASR systems were popular, having been used in an estimated 93,000 patients worldwide. Unfortunately the device often had problems with loosening, and the patient often required revision surgery.
The FDA predicated its approval of DePuy’s ASR devices for market and sale within the United States on its substantial similarity to another DePuy product—the Pinnacle hip replacement system. Although the Pinnacle hip replacement system is similar to the ASR in that it is a metal-on-metal hip replacement system (which has gained popularity in the orthopedic community), there are several differences in the design of the two products.
The main difference between the ASR and Pinnacle designs is that the Pinnacle system is a “modular” system, meaning that there are multiple parts that work together, while the ASR system is one unit. Additionally, the Pinnacle system is fastened to the bone with screws while the ASR attaches through natural bone ingrowth. In other words, the bone grows into and around the device, fastening it in place.
Nevertheless, the FDA has heard over 500 complaints regarding the Pinnacle system, mostly of the device loosening, leading to severe pain when doing simple tasks. However, there is another potential problem with the Pinnacle system that has recently come to light. A study published in December has shown that due to the metal-on-metal nature of the Pinnacle system, metal may flake off and embed itself in the surrounding tissue, which puts the patient at risk of developing metal poisoning. At least one plaintiff filed a lawsuit since the study was published, alleging this very issue with his Pinnacle system.
Metal poisoning is a serious condition that occurs when a metal builds up in the body to a toxic level and may destroy tissue or result in death. The symptoms of metal poisoning vary from case to case but will mostly result in feelings of disorientation, confusion, or malaise in the sufferer. It may also physically manifest itself with dizziness, headaches, or gastrointestinal problems.
There has yet to be any mention of a recall as of yet, though since ordering the removal of DePuy’s ASR system from the market, the FDA will likely be watching the Pinnacle situation carefully. Johnson & Johnson has already set aside $922 million of its reported $1.8 billion 2010 profit for litigation regarding the ASR hip replacement systems. If there is a rise in the already numerous complaints regarding the Pinnacle hip replacement system a recall may follow, which could lead to a DePuy Pinnacle class action lawsuit.
If you have a DePuy Pinnacle hip replacement system and have experienced loosening, required revision surgery, or suffered symptoms of metal poisoning, then you may have a claim against DePuy and Johnson & Johnson. You could recover for medical expenses, lost wages, and pain and suffering. The Rottenstein Law Group can help you pursue your claim. RLG’s lawyers have 25 years of experience defending the rights of their clients. For a free consultation with RLG, please fill out this contact form.
