DePuy Synthes is one of the orthopedic franchise acquired by Johnson and Johnson in 1998 and is involved in manufacturing, designing, marketing products for repairing, reconstructing, correcting, treating various traumatic skeletal damages, bone fractures, and joint deformities.
DePuy Attune Knee System is one of the well-known products used for Total Knee Replacement Prosthesis of DePuy Synthes. Posterior Stabilized (PS) Femoral Component and PS Fixed Bearing Inserts are two parts of the Prosthesis, which was approved by the FDA using the 510k process. It was believed that the product was one of the largest development catering needs of patients, surgeons until gradually complaints started popping up.
Some instances like the loosening of implants and the entire knee becoming unstable were found which proved that the device is defectively designed. The only way to manage these failures was revision surgery which was painful and all the more troublesome to patients. The concern was later investigated and it became evident that the surface of these devices was very smooth so the surgical glue wasn't able to hold the joint in place.
Knee surgery takes about two hours. The surgeon removes a damaged bone and replaces it with an Attune knee prosthesis. Surgeons use cement to keep the wire in place. In the weeks leading up to surgery, patients can receive physical therapy. Their doctor can also put them on a weight loss program.
After surgery, surgeons will arrange a follow-up visit. The doctor will perform a knee replacement to see if it is healing and working properly. Patients should inform their surgeon if he experiences problems with the knee replacement.
A 2017 study looked at the release of DePuy Attune tibial. Investigators found that Attune's knees had an "unusually high" level at the beginning of the failure. They received more than 230 reports from the FDA regarding Attune tibial relaxation.
Research has suggested that the problem is the failure of cement to connect bone implants. The authors of the study also suggested that it was an under-reported condition of Attune's knees.
Attune knee joints can also break. This can also cause discomfort, pain, or other problems. Loosening can also lead to broken bones. Loosening can cause parts to wear out faster than expected.
Patients should always be aware of the signs and symptoms of Attune knee problems. Pain and instability are among the first clear warnings of flexible knee flexion.
Attune knee specialists filed DePuy Attune's first knee replacement case in September 2017. Many other Attune patients have worn suits since then.
Attune cases are in the early stages. There have been no court decisions or residential properties advertised yet. Attune knee lawyers take on new cases.
Depending on the number of reported failures, there may be hundreds of Attune knee replacement cases. If that happens, attorneys may ask to be arraigned in a multi-party court (MDL). MDLs allow multiple, similar cases to go very quickly through the legal process.
An FDA announcement has it that a small metal coil may appear during surgery. If that happens, the coil may fall to the surgical site.
The portion, called Balseal, is small. Surgeons may not notice the wound. There was a risk that surgeons might leave it in the patient's body. The FDA approved it through the 510 (k) agency use process.
This process allows medical devices to make you sell faster. It allows manufacturers to bypass most of the FDA's most difficult approval procedures.
DePuy produces other knee-replacement implants. This includes one product line that has been around since the 1970's.
DePuy's Sigma Knee System is among the company's most popular knee pads. Doctors have placed DePuy Sigma's knees on an estimated 1.7 million patients.
In 2010, DePuy recalled its ASR XL Acetabular System and ASR Hip Resurfacing System because a large number of patients required revision surgery after receiving the implants. The company also stopped selling the all-metal versions of the Pinnacle system of implants because large numbers of consumers claimed the devices were faulty and led to a type of metal poisoning known as metallosis.
Plaintiffs in the Pinnacle cases claim that J & J and DePuy were well aware of the flaws in the Pinnacle device, however rather than issuing a recall of the device, marketing tactics were increased. The companies claimed the Pinnacle was the best hip implant option for younger patients with an active lifestyle, yet some patients found themselves unable to even walk without painless than a year after the device was implanted.
After hip implantation, severe inflammation in the hip and thigh areas can be caused which includes chronic pain in the thigh, hip, and groin areas, bone and tissue deterioration, and various other physical damages. When the cobalt and chromium ions entered the bloodstream during surgery, the effects can be even more damaging which include severe headaches, visual disturbances, memory loss, vertigo, hearing loss, DNA disruption, and gastrointestinal disorders.
Johnson & Johnson reversed its prior position on the Pinnacle hip lawsuits in the year 2019, agreeing to settle the bulk of consumers’ lawsuits which alleged the Pinnacle hips were defective and that J & J and DePuy misled patients about the danger of the implants. While DePuy marketed the Pinnacle implants as having a five-year rate of more than 90 percent, European health regulators found that number to be about 5 percent. This settlement agreement came two weeks after J&J agreed to pay $120 million to resolve claims of deceptive marketing to state attorneys general. In an earlier Pinnacle settlement, Johnson & Johnson paid about $125,000 per case to resolve roughly one-third of the more than 10,000 Pinnacle implant claims.
DePuy introduced its LCS knee replacement in 1977. Surgeons administer 700,000 devices to patients. The company expanded its product line in the 1990s and changed its name to LCS Complete. DePuy still uses materials for the original design.
DePuy also produces software called TruMatch Personal Solutions. TruMatch includes a set of customizable tools and computer software. These allow surgeons to customize knee replacements depending on the patient's condition.
As patient-centered care continues to drive new medical implications, patient outcomes reported (PROMs) are important international standards for understanding patients' perceptions of their health and recovery, as well as the quality and satisfaction of care they receive. The short-term results of two international, multidisciplinary studies have shown that the ATTUNE Knee System has significantly improved outcomes, compared to other leading knee programs, a wide range of PROMs, including Quality of Life, Daily Living Activities, Pain, Sports & Recreation for at least one year. The Oxford Knee Scores (OKS) also reported significant improvements compared to the original base.
Drs. Douglas Dennis said that for his TKR patients, being able to feel the positive impact they have had on their quality of life continues to be one of the most rewarding aspects of my career. ”
With the latest integration in architecture, kinematics, engineering, and building materials, DePuy Synthes continues to expand the ATTUNE Knee platform to provide knee-jerk solutions that meet the full needs of the patient.
Launched in 2019, ATTUNE Cementless Knee uses the same technology as the ATTUNE Knee System and Rotating Platform, with the added benefit of biologic adjustment and POROCOAT ™ Pating Coating. It is also available in hybrid design which includes a Magnetless Femoral Component with a Fixed Bearing base or Rotating Platform Tibial base. ATTUNE S + Technology Tibial Base is designed to improve tibial fixation with its new combination of macrolock features and microblast surface finish on the tibial base.
In addition to the technology of insertion and the surgical procedure itself, DePuy Synthes invests in innovation throughout the continuum of care to improve patient satisfaction and outcomes, working with hospitals and health systems to increase the TKR value of patients and surgeons. This includes the introduction of VELYS Digital Surgery, an integrated orthopedics technology platform that uses more data understanding
At least 60,000 patients in the united states were then and saw that they had a full knee replacement. While the majority of knee replacements can last an average of 20 years, the patients and the doctors claim that the TONE device, which caused the beginning of the fault, resulting in pain, limited mobility, and the need to do some fixes.
DePuy Synthes division of the Johnson & Johnson family of companies, and their HARMONY, the knee, the largest company in the field of research and development. The system is designed to return patients to a normal life after the surgery.
The search of the US Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database for the detection of a number of patient reports of problems with the match. The data show that there is a large number of cases of debonding at the border of the tibial implant and the cement of the symptoms, which typically occur two years after the implantation of the patella of the system. This was the patch that resulted in patients experiencing knee swelling, so that the excess fluid and the pain when you stand, and limited range of motion. The patient's history is as follows:
"The DePuy ATTUNE knee implant failure. Not on his hands and knees. Constant, severe pain. The loss of mobility and strength. It gives you the ability to manage your knee with an ace bandage). Popping, clicking and rattling noise. The knee is constant, warm, and make the. " "I had a TUNE DePuy knee replacement, and a little to the left knee joint, and to have experienced the pain and stiffness then. It fell apart in my life."
The research is published in the June 2017 issue of knee surgery, it was found that" a high proportion of early failures " in the FADE system. The researchers analyzed the three hospitals, databases, and found that 15 of the patients who received the ATTUNE system, which is undergoing tibial devices, removal, and calls for revision surgery. Of the 15 cases, only two of them have been found to be impaired by the x-ray. Therefore, the researchers have come to the conclusion that this disease may be underestimated due to the inability of the medical images, in order to find the problem.
DePuy Synthes, acquired by Johnson & Johnson (J&J) in 1998 is one of the orthopedic franchisees involved in manufacturing, designing, marketing products for repairing, reconstructing, correcting, various bone fractures and joint deformities. DePuy provides the following product for Hip Replacement Surgery: DePuy Articular Surface Replacement (ASR) Hip Resurfacing System, ASR XL Acetabular System for total hip replacement, and Pinnacle hip replacement system being their top hip replacement products.
The DePuy Pinnacle was initially approved by the U.S. Food and Drug Administration (FDA) in 2000. The 510(k) approval was based on similarities to the other implant and hence did not undergo the usual safety tests. ASR and ASR XL have been recalled in 2010 for their failure, whereas the sales of metal Ultamet liner ended in May 2013. However, the sales of Pinnacle hips made from other materials were not affected.
DePuy stated the reason for failure as component loosening, infection, dislocation, component malalignment, fracture of the bone, metal sensitivity, and pain. Additional complications include bone staining, necrosis, swelling, increased metal ion levels in the blood, nerve damage, tissue damage, and/or muscle damage.
In the year 2017 when Johnson & Johnson (J&J) and its subsidiary company DePuy were busy settling as many as 11,000 DePuy ASR hip implant lawsuits. The orthopedic device manufacturer was confident about their product safety for hip implant surgery. Johnson & Johnson refused to recall the Pinnacle hip implant, despite the more than 9,000 claims from Pinnacle victims. At that time, the Pinnacle hip lawsuits alleged the Pinnacle was defectively designed.
Plaintiffs claimed when they engaged in any level of activity, the metal parts of the implant would come into contact with one another, rubbing together and causing cobalt and chromium ions to imbed into surrounding tissues or to enter the bloodstream.
More than one million patients have received Pinnacle Hip Solutions cups, according to DePuy. The devices are implanted into the pelvis during partial or total hip replacement surgeries to relieve pain or increase mobility. Today, the Pinnacle cups come in ceramic-on-polyethylene and metal-on-polyethylene options depending on the patient.
Attune knee replacement was engineered by DePuy as one of the most advanced and technically safe devices in the market. Hundreds of reports about the device getting loosened up have been filed by patients across the country. There has been at least one study proving the "unusually high" failure rate for Attune knee implants. The problem usually originates from cement not being able to bond with the components of tibia bones present in the lower leg. Hundreds of complaint related to the complication of Attune Knee problem has been sent to the U.S. FDA.
In December 2010 FDA DePuy got approval. The approval was given by the FDA through its agency's 510(k) clearance process. By this process, marketing medical devices can be done in a faster way and it also enables the manufacturer to skip FDA's strenuous approval process.
DePuy's Sigma Knee System considered being company's best knee implant device has been implanted in around 1.7 million patients. DePuy was introduced in 1997, just a year before being acquired by Johnson & Johnson. In September 2017 the first lawsuit for DePuy Attune Knee System was filed in Alabama. After that more lawsuits were filed with claims that cement failed to connect the implant to the patient's bones. This led to the loosening of artificial knees which resulted in instability, persistent pain with decreased range of motion, and unusual swelling.
The Kansas City Business Journal did a comparison of reported problems with the close competitor of Attune knee, that is Zimmer's Persona knee implant. The Attune implant by June 2017 has accumulated nearly eight times the adverse event reported to the FDA. As per the journal, Attune failures require as many as 10 surgeries to replace the comparison of the device compared to the Persona.
Serious Alleged Injuries May Include:
- Premature Loosening
- Severe Pain
- Inflammation And Swelling
- Limited Mobility
- Infection
- Bone, Joint, Muscle Or Neurological Damage
- Instability When Standing Or Putting Weight On The Implants
FDA Safety Warnings:
Hundreds of complaints were filed with the FDA against the implant. According to the FDA, a small wire coil on the instruments, called a Balseal, could come off during surgery and fall into the wound which might remain in the patient’s body and remain unnoticed.
DePuy Attune Knee Recall:
2013: FDA warned DePuy for its diaphyseal sleeve, a part which was faulty and was recalled.
2015: DePuy recalled 3,474 defective surgical tools used in Attune knee surgery.
Legal Updates:
The first lawsuit was filed on September 2017 in the Circuit Court of Tuscaloosa County by Cunningham Bounds LLC which alleged that Johnson & Johnson and its subsidiary DePuy Synthes created a defective device. Multiple lawsuits are now getting filed against the manufacturers.
News
Aug 22, 2018: Arthrex Accused Of False Marketing Recalled Knee System
In an August 8 complaint filed in the U.S. District Court District of Pennsylvania, a plaintiff alleges that Arthrex Inc.’s recalled iBalance knee replacement device, which he was implanted with, was faulty and required him to undergo revision surgery. The plaintiff blames the company for conducting inadequate testing before exclusively marketing the device. The device was recalled in February 2015, when Arthrex sent out urgent medical device voluntary recall letters to distributors, surgeons, and medical centers, reporting the removal.
More than 4 million Americans have undergone a knee replacement, and thousands have reported faulty device designs. Around 2,378 Arthrex iBalance units were affected by the 2015 FDA Class II recall. DePuy Synthes Attune, Zimmer, and several other manufacturers are facing claims over faulty knee replacement systems causing severe internal injuries to patients.
Evidence:
- Usage Of Attune Knee System
- Detailed Operative Reports
- Implant Sticker And Relevant Details Like Product Code, Manufacturer, Lot Number
- Follow-Up Complications And Their Treatment After Attune Knee System Insertion
Medical Record Review and claim validation of Attune Knee System case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.