Product recall attorneys at Pintas & Mullins Law Firm report that DePuy, a part of Johnson & Johnson, recently issued a Class I recall of its LPS Diaphyseal Sleeve. The device is used in reconstructive knee surgery, and was recalled due to increased risk of fractures.
The FDA recently notified healthcare professionals of the recall, which is affecting all devices manufactured between 2008 and July 20, 2012. There have been at least ten reports of the device malfunctioning to date. The Diaphyseal Sleeves have an increased risk of fracturing at the joint, which could lead to loss of knee function, infection, compromised soft tissue, or even loss of limb or death.
In its recall notice, the FDA stated that hospitals and surgeons must immediately stop distributing and using the recalled devices. The agency also recommended surgeons communicate with their patients who received the implants, and discuss the potential risks with them. Warning signs that indicate the device may be malfunctioning include pain, swelling, redness at the knee, unusual warmth, looseness, instability, stiffness, decreased walking ability, unusual sounds from the device, and infection.
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Class I recalls are the most serious type, intended for drugs and devices that show a reasonable potential of serious adverse side effects or death. This means that injuries from DePuy’s knee implant device may lead to permanent disability, decreased quality of life, and other serious complications. Unfortunately, many patients are unaware of the type or brand of medical devices they are implanted with, making recalls of this kind all the more dangerous. If you underwent knee revision surgery since 2008 and were implanted with a joint device, contact your physician immediately.
Johnson & Johnson’s DePuy is currently facing nearly 10,000 lawsuits for its metal-on-metal hip implants. The ASR and Pinnacle hip implants have a high rate of failure and pose a significant risk of releasing toxic amounts of metal ions into the bloodstream. Over time, the metal implants may cause damage to bones, muscle and other tissue in the hip area.
The ASR implants were recalled in 2010 when over 12% of them failed within a few years after implantation. The devices are so dangerous in fact, that earlier in February 2013 the FDA issued a proposal that will take metal-on-metal hip implants off the market completely until manufacturers submit pre-market approval applications. An estimated 500,000 patients implanted with the artificial hips suffered from early device failure.
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The high failure rates of these devices are due in no small part to past regulations that did not require the devices to undergo any clinical testing in humans before their release onto the market. This was made possible by the Medical Device Amendments of 1976, which has only recently been reconsidered.
The Zimmer NexGen CR-Flex Porous Femoral knee replacement system is another example of a defective device that was allowed on the marketplace without pre-market testing, and consequently failed in thousands of patients. One study found that, after two years, 9% of patients required corrective surgery and 36% of patients showed signs of the Zimmer NexGen device loosening.
When medical devices like hip or knee implants fail they require painful corrective surgeries, which can lead to catastrophic internal injuries. This is the basis for the litigation surrounding the implants, as hundreds of thousands of American are forced to suffer the effects of defective devices. Patients can sue these manufacturers for compensation from lost wages, corrective surgeries, any future care, medical bills, and pain and suffering.
The ASR implant lawsuits against DePuy just recently started going to trial. In August 2012, Johnson & Johnson agreed to pay about $600,000 to settle the first three cases. The company has reportedly set aside more than $2 billion in anticipation of these lawsuits.
Knee and hip implant lawyers at Pintas & Mullins Law Firm hope the FDA starts to regulate these manufacturers more thoroughly, to prevent dangerous and defective products from entering the market in the first place. If you or someone close to you was implanted with the recalled Diaphyseal Sleeve or another defective knee implant, contact our lawyers for a DePuy knee recall lawsuit.