DePuy, a subsidiary of Johnson and Johnson, has become notorious for recalls of late. DePuy recalls for faulty hip replacement parts were issued in large number in 2017. The company was forced to pay $2.5 billion to settled a national multidistrict litigation, comprised of 8,000 individual DePuy recall lawsuits. Evidence uncovered in the DePuy recall lawsuits revealed that company officials knew of the tendency for its hip replacement systems to fail long before the DePuy recall was issued.
There are parallels between the DePuy recalls for knee and hip replacement systems. While there have been several DePuy knee recalls in the past two decades, there are several DePuy knee systems still in use that have been shown to fail prematurely. Thousands of Americans have suffered severe pain, permanent bone loss and joint damage, and lost wages and enjoyment of life during lengthy recovery periods.
The FDA has received adverse event reports for several DePuy knee replacement components yet many of these remain on the market and in wide use. It is the belief of our attorneys handling national DePuy knee cases that filing a claim is the only way to elicit a DePuy knee recall for all the products that pose a risk to consumers. Sometimes the threat of litigation is the only means to get a company to take steps to protect consumers.
When doctors and patients encounter problems with a medical device, they may file an adverse event report to the FDA's FAERS (Federal Adverse Event Reporting System) database. This allows federal regulators to detect patterns of defects and early failure. If enough adverse event reports are filed on knee replacement systems, a FDA DePuy knee recall is likely to follow.
According to FDA DePuy knee reports, the most common causes of DePuy knee failures are loss of/failure to bond, worn components, fracture, loss of osseo-integration, and metal debris deposited in the joint. Signs of early device failure include tibial loosening, pain, infection, disassociation of insert, change in position of components, patella-femoral tracking, and lateral release,according to FDA reporting.
If you or a loved one is suffering one or more of these symptoms or another related problem, please contact your doctor immediately. In many cases, DePuy knee failure requires complex revision surgery and a long rehabilitation period.
This page provides an overview of major DePuy knee recalls to date, starting with the most recent. For a full list of DePuy knee recalls that have been issued in the past two decades, visit the FDA database.
The balseal, which is a small wire spring coil used to connect one surface to another, has a tendency to become damaged and come off of the device. This FDA DePuy knee recall was based on reports of the piece falling off during surgery and being inadvertently dropped into the patient's incision without the surgeon's knowledge, causing complications to the patient. This was a Class II recall, in which surgeons were were told how to correct the problem.
Another part of the LPS system was the subject of a second Class I DePuy knee recall. In July of 2013, the LPS Lower Extremity Dovetail Intercalary Component was recalled because another part--this time the female component of the knee replacement system--was fracturing at the dovetail under the normal physiologic loads that result from walking. Again, this FDA DePuy knee recall called upon surgeons to cease the use of this device immediately. Adverse event reports to the FDA listed severe pain, infection, loss of function or loss of limb, neurovascular injury, and the need for revision surgery as possible side effects.
On January 4, 2013, an FDA DePuy knee recall was issued for a component known as LPS Diaphyseal Sleeves. Due to the severity of adverse event reports--that the knee replacement part was prone to failure under the stress caused by everyday walking--this DePuy knee recall was deemed Class I, the most severe classification. Titled an Urgent Medical Device Recall, the warning ordered surgeons to immediately stop using the device. The ten reports filed to the FDA outlined a range of problems that could occur when the part fractured at the sleeve joint, including loss of function of the leg, infection, compromised soft tissue, loss of the limb, and even death. This DePuy recall pertained to parts that were manufactured between 2008 and 2012.
Due to higher-than-expected knee replacement revision surgery rates, the company issued a DePuy knee recall in 2009 for its LCS Duofix femoral component. Never approved for use in the United States by the FDA, the recall for this DePuy knee system was prompted by adverse event reports out of Australia.
In 2008, DePuy issued a recall itself for a component of its LCS Knee Orthopedic Knee implant. A part known as the meniscal bearing insert was mislabeled, causing surgeons to use the wrong size part during surgery. This particular DePuy knee recall occurred promptly and was not the result of poor design, like so many of the other DePuy knee recalls.
In 2001, Hyamer liners used in artificial knee implants were the subject of a DePuy recall issued by the British Medical Devices Agency. A sterilization procedure utilizing gamma radiation which was implemented during the production process is thought to have made the components brittle and thus prone to breakage. As many as 67.6% of patients suffered DePuy knee device failure in the first five years after the device was implanted--13x the expected failure rate--prompting the first DePuy knee recall.
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