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DePuy Synthes Attune Knee Implant System
By Jane Mundy
Knee implant lawyers are investigating complaints involving premature failure of the DePuy Attune Knee System. Although the medical device company—DePuy Synthes-- has not yet announced an Attune knee implant recall and DePuy Attune knee lawsuits have not yet been filed, patients experiencing debilitating knee failure with the Synthes Attune system are filing personal injury and defective device claims with Attune knee lawyers.
DePuy Synthes Attune Knee Replacement SystemThe Attune Knee Implant System, which is manufactured by DePuy Orthopaedics and a subsidiary of pharmaceutical giant Johnson & Johnson, is promoted as providing patients with a better range of motion and increased stability.
DePuy and the FDAFrom 2003 until 2013, DePuy recalled 277 devices or components, four of which were Class I recalls, or products with flaws that could seriously harm patients, according to Consumers Union. The majority (270) were Class II recalls, described by the FDA as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
In 2011 the FDA sent DePuy a warning letter, stating the company was marketing and selling several products that had not received approval, that several devices or components had been altered, and were currently misbranded as safe and effective. (DePuy claimed their devices could be approved through the 510(k) process.) As a resultDePuyvoluntarily recalled a number of its knee replacement components.
DePuy Attune Knee Replacement and the FDAWhen submitted to the FDA for premarket approval in 2010, DePuy claimed that its Attune Knee System was “substantially equivalent to currently marketed devices,” including Zimmer’s NexGen CR Knee System, which was recalled in 2015 due to its early failure rate.
Approved by the FDA in 2013, the Synthes Attune knee implant is one of DePuy’s most popular and widely used knee replacement devices and according to DePuy Synthes, its largest research and development project in the company’s history Since its approval, the FDA Adverse Event Reporting System has received numerous complaints from patients who reported complications with the Attune knee replacement system, resulting in revision or reconstructive surgeries. One of the most common issues is that the tibial plate loosened or was not properly fixed to the tibia.
In June 2015, the FDA issued a recall for an Attune Knee Tibial Articulation Surface instrument, announcing that the Balseal, a small wire spring coil located on the post feature of the Attune Knee Tibial Articulation Surface Instruments used in the range of motion testing to aid in tibial location prior to drilling peg holes, can become damaged and detach. This may allow the coil to enter the surgical site during the knee replacement surgery and remain in the patient if the surgeon is unaware that it detached. The recall covered 3,474 units.
DePuy Synthes Attune Knee FailureKnee replacements are typically expected to last a minimum of 15 years, but some fail much sooner and some patients report that their DePuy Synthes Attune Knee Replacement system is failing only a year or two after implant. Most of those patients report a loss of, or lack of bonding of the Attune knee component to the bone, which can require additional surgeries or procedures.
A studytitled"Unusually High Rate of Early Failure of Tibial Component in ATTUNE Total Knee Arthroplasty System at Implant-Cement Interface" and published in the Journal of Knee Surgery (June 2017), showed that all 15 patients in the study had to undergo revision surgery within two years after their knee replacement surgery.
Patients who have complained of Attune Knee Implant failure have described the following symptoms:
The above symptoms can lead to:
In 2015, DePuy Synthes orthopaedic sales in the U.S. were up 3.5 percent to $5.3 billion. Knee replacement sales made up more than a quarter of that amount, with a total of $1.4 billion.
DePuy Synthes Attune Knee Replacement Legal HelpIf you or a loved one has suffered similar damages or injuries, please fill in our form and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
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DEPUY SYNTHES ATTUNE KNEE REPLACEMENT LEGAL ARTICLES AND INTERVIEWS
Depuy Attune Knee Victim “Pissed off that there’s No Way to Fix this Defect Without Litigation”
October 16, 2017San Jose, CA: Mike says he’s in worse shape now with his DePuy Synthes Attune knee replacement system than when he was injured after falling off a ladder. And he’s pissed off, to say the least [READ MORE]
Three Strikes after Depuy Synthes Attune Knee, First Lawsuit is Filed
September 21, 2017Mobile, AL: An Alabama law firm has announced it has filed the first DePuy Synthes Attune knee lawsuit in the U.S., alleging premature failure of the knee replacement system [READ MORE]
Coming Unglued – DePuy Synthes Attune Buckles at the Knees
September 9, 2017West Chester, PA: Evidence continues to mount that the DePuy Synthes Attune knee replacement device may be a defective product that can harm patients. There are many reasons for hip and knee implant failure, but a major culprit in the malfunction of Attune knees appears to be something rather technically referred to as “tibial baseplate failure,” or “debonding.” In everyday terms that means the artificial knee comes unglued from a patient’s lower leg [READ MORE]
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i am not sure what kind of system they used on my knee, I had two knee replacements plus a forced loosening of the artificial knee, where they give you some local anesthesia and force the knee to move. The surgeries were all done in Las Vegas, and the doctor who performed them won't take my calls because I guess he considers me a failed patient. I need to know how I can get that info out of the doctor's office. As one of my doctor's warned me, this surgery might not take care of your pain, and he was right.
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