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Problems with a number of different knee replacement systems have surfaced in recent years. As result, product liability lawyers are reviewing potential claims for individuals nationwide who may have received a DePuy Attune, Exactech Optetrak, Arthrex IBalance or other defective implants.
REVIEW A KNEE REPLACEMENT CASE: Unreasonably dangerous design problems have resulted in high rates of failure and revision surgery for certain implants. To help individuals and families determine whether they may be entitled to financial compensation, knee replacement lawyers provide free consultations and case evaluations.
OVERVIEW: Although knee replacements are designed to last 15 to 20 years, problems have been linked to several different systems used in recent years, which may cause individuals to experiencing complications, such as:
- Severe Pain, Swelling and Loss of Mobility
- Knee Implant Failure or Loosening
- Revision Surgery
In many cases, it appears the manufacturers knew or were warned about these problems for years, yet withheld information from consumers and the medical community. As a result, financial compensation may be available through a knee replacement lawsuit. It is not necessary to know what type of an implant was used during your surgery, a product liability lawyer can help!
DEPUY SYNTHES ATTUNE KNEE LAWSUITS: The DePuy Attune Knee System was approved by the FDA in 2010 through the controversial 510(k) fast-track approval program, meaning that DePuy and it’s parent company, Johnson & Johnson, only had to prove that the device was “substantially equivalent” to existing implants. Since about March 2013, the DePuy Attune knee has been widely used by surgeons throughout the United States.
Although the DePuy Attune knee was marketed as an innovative design, which was designed to provide a better range of motion and stability among individuals doing every day activities, it has been linked to a higher-than-expected rate of problems and failure, often resulting in the need for revision surgery to remove the DePuy Attune knee and replace it with another device.
In many cases, the DePuy Attune failures have been linked to tibial baseplate loosening, after the cement bond failed between the tibial baseplate and the rest of the implant.
As of June 2017, the FDA has received about 1,400 reports of DePuy Attune Knee problems through its Manufacturer and User Facility Device Experience (MAUDE) system, which receives reports of adverse medical device reports from manufacturers, as well as importers and places where the devices are used. Of those 1,400 reports, 633 involved patients who had to undergo revision surgery to have the devices removed.
EXACTECH OPTETRAK KNEE SYSTEM PROBLEMS: Lawsuits over Exactech’s Optetrak Total Knee Replacement have also been filed, alleging design defects and problems.
Since about 2012, the FDA has received large numbers of adverse event reports involving Exactech Optetrack tibial loosening, pain, loss of mobility, swelling, and the need for revision surgery. Afterwards, the manufacturer removed a “finned” tibial tray design used with the implants and replaced them with a new design known as a “fit” tibial tray. Some have considered this a silent knee replacement recall, designed to prevent negative media coverage.
ARTHREX IBALANCE KNEE SYSTEM PROBLEMS: Since about 2014, problems with the Arthrex IBalance knee may have caused individuals to require removal of the implant, according to allegations raised in lawsuits.
In February 2016, an Arthrex iBalance recall was issued for some devices, indicating that the outer surface of the implants were smooth instead of textured, which could result in a failure to bond and, ultimately, implant failures.
A number of Arthrex IBalance knee problems have been linked to loosening, which has resulted in catastrophic implant failure.
KNEE REPLACEMENT INFECTION LAWSUITS: In addition to cases for unreasonably dangerous and defective knee implants, many individuals have experienced serious complications due to infections caused by the use of a 3M Bair Hugger warming system, which is commonly used during hip and knee replacement surgical procedures to help control body temperature.
The forced air warming system is found in many operating rooms nationwide, but may cause bacteria and contaminants to enter the sterile surgical site, leading to devastating deep joint infections, which typically require complex treatment.
The Bair Hugger warmer contains a portable heater/blower unit, with a flexible hose that is hooked up to a disposable blanket that is positioned over surgical patients. The forced air warming blanket is designed to deliver warm air onto a patient during an operation to keep the wound area and patient appropriately heated, which reduces the risk of bleeding and shortens recovery times.
According to allegations raised in Bair Hugger knee replacement infection lawsuits, the forced air warming device disrupts the laminar air flow in the operating room. As a result of the manufacturers’ failure to warn consumers and the medical community, cases are being pursued nationwide.