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DePuy Orthopedics has issued a recall for two of its hip replacement systems following reports indicating a higher-than-normal implant failure rate. DePuy recall came after more than expected number of people had to undergo secondary surgery due to hip implant failure. Since their approval in 2003, DePuy ASR hip implants have been used in over 93,000 hip replacement surgeries. Hip implants generally last 15 years; however, many patients have complained that their artificial hips lasted only two or three years, following which they were required to undergo expensive and painful revision surgeries, which caused them more pain and loss of money.
The FDA has received over 300 complaints against DePuy Orthopedics regarding defective hips. Complaints against DePuy started surfacing in 2009; however, DePuy issued a recall only after a long wait of about 18 months, after its defective product had caused more harm to many other patients throughout the country.
DePuy has recalled both products because of their high failure rate.DePuy’s metal-on-metal hip products use a metal ball and metal cup, which are installed in the place of the natural ball and socket hip. When DePuy launched its new metal-on-metal hips, it claimed that the product was stealthier than traditional hips made of metal and plastic. However, it ignored the risk of metal toxicity posed by metal-on-metal hip products. Even a number of complaints registered against DePuy claim that the metal-on-metal hip implants caused metal toxicity in many patients.
Analysts believe that when metal ions rub against each other as a result of friction and movement, these metal particles spread into the surrounding tissue and bloodstream. Further, these metal ions do not allow the cup to bond properly with the bone, causing cup loosening and hip fracture, besides other complications, including persistent pain, inflammation, discomfort, lethargy, dizziness, headache, gastrointestinal problems, food allergies, muscle and tissue damage, bone fractures, and Pseudotumors.
Metal toxicity causes heart problems, skin rashes, nerve damage, depression, numbness, loss of sensory and
cognitive capabilities, and confusion.
A number of people who received DePuy hips have complained that they had to suffer from hip fracture, cup dislocation, and cup loosening, which caused them intense pain and swelling in the hip area, weakness, and they experienced walking problems. A significant number of such patients had to undergo secondary surgeries to have their defective hip devices removed and replaced, which caused them further emotional and physical pain.
Those who have undergone revision surgeries might again require additional surgery if further complications arise. Those who have not yet undergone revision surgery should undergo additional testing to check that their hip replacement product is functioning properly.
Some doctors have complained of a fundamental design flaw in ASR implants, saying that the shallow DePuy hips are difficult to implant. Many others have revealed that they did not find any kind of bony ingrowth in the patients they operated, which is required to keep the implant in place. Almost all surgeons have expressed their concern about secondary surgeries, saying these can be more extensive and complicated, because they are required to remove defective hips and attach new components to the bones.
DePuy Orthopedics got the two defective products approved fairly easy by exploiting FDA’s 510(k) approval process. The manufacturer told the FDA that the hip implant systems were substantially akin to other hip replacement products, claiming that the metal-on-metal hip implants were better and more durable than all other hip implants sold in the market.
More than 150 product liability lawsuits have been filed against DePuy Orthopedics for selling faulty hip implants. Most of the lawsuits seek compensation for hospital medical bills, surgery cost, lost wages, and revision surgery expenses. The plaintiffs allege that DePuy failed to inform them of the potential dangers associated with its defective hip implants.
DePuy is not the first hip implant manufacturer to have recalled its defective products. Many other manufacturers face similar lawsuits for negligence in marketing defective products, which have caused severe side effects and serious complications in many cases. Earlier, Stryker, St. Gobain Desmarquest, Suzler Orthopedics were among the hip implant manufacturers that recalled their replacement systems following complaints of product failure.
Zimmer Durom Cup was recalled following numerous complaints that the product was defective and broke down in a couple of years following the implantation. Patients complained that failure of the hip implants meant that they had to undergo revision surgery. Many patients have filed negligence and product liability suits against the manufacturer Zimmer Inc.
Trident PSL and Hemispherical Acetabular Cups were recalled by Stryker as it had failed to maintain manufacturing procedures conforming to the FDA guidelines. The FDA warned Stryker that its product was not worth use of patients requiring hip implant surgery.
DePuy has agreed to bear the cost of medical care and treatment for some patients. It has declared that it will bear “reasonable and customary costs of monitoring and treatment for services,” which include the cost of revision surgery. However, the DePuy proposal does not talk about other expenses, including lost wages. Patients have borne immense pain and suffering and high treatment expenses. Many patients even complain of reduced earning capacity following revision surgery, which has considerably brought down their annual income. Now who is not responsible for that? Of course, DePuy Orthopedics, which did not warn patients of the possible side effects of using its product.
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