The ATTUNE® total knee replacement system is a novel design that was introduced by manufacturer DePuy Synthes to improve longevity and patient outcomes. Unfortunately, this knee replacement system has been found to have a high rate of early failure. According to a study published in the September 2017 edition of the Journal of Knee Surgery, this unusually high rate of failure is due to debonding of the tibial (inner lower leg bone) implant/cement interface.
Product Liability Attorney for Faulty Medical Devices
Our team of top product liability attorneys at Meyers & Flowers have issued a warning about the ATTUNE® total knee replacement system. We have a history of success and winning high value awards for our clients, including people who have suffered with defective knee replacements. Our practice is focused on prosecuting large corporate medical product and device manufacturers, such as DePuy Synthes.
What Is Total Knee Replacement?
Knee replacement surgery is a common procedure performed on patients whose knees have been damaged by:
- Excessive wear and tear
It is typically recommended after noninvasive treatments, such as physical therapy and medications to reduce inflammation, have failed. This orthopedic surgical procedure (also known as arthroplasty) is performed to relieve pain, restore lost mobility, and return the patient to normal activities.
In total knee replacement, the surgeon removes damaged surfaces of the knee joint and replaces them with a prosthetic implant made of plastic, metal, or a combination of both. DePuy Synthes’ ATTUNE® Knee Replacement System is a medical device used in knee replacement surgery that has been shown to be failing prematurely.
Problems with the ATTUNE® Total Knee Replacement System
Researchers who conducted the study published in the Journal of Knee Surgery noted a large number of patients in a short period of time who needed revision surgery after receiving ATTUNE® total knee replacement. They also noted multiple reports of the same failure mechanisms filed in the Manufacturer and User Facility Device Experience (MAUDE) database.
The Facts: Failure of the ATTUNE® Total Knee Replacement System
These researchers evaluated clinical and radiographic findings and findings occurring during revision surgery on patients who had the ATTUNE® knee replacement. They reviewed the findings from the MAUDE database and three hospital databases.
Within two years after receiving the ATTUNE® total knee replacement system, patients presented with symptoms including:
- Pain with bearing weight
- Pain in the front of the knee localized in the tibial area
- Effusion (increased fluid within a joint cavity)
- Decreased range of motion
Radiographic and intraoperative findings revealed gross loosening of the tibial (inner lower leg bone) component at the implant cement interface. Researchers found 21 reports of this tibial loosening in a two-month period in the MAUDE database.
Clinical and Intraoperative Findings in Patients with ATTUNE® Total Knee Replacement
Patients involved in the Journal of Knee Surgery study had no initial symptoms, but gradually developed increasing pain, fluid on the joint, and decreased range of motion. These symptoms occurred between one month and two years after knee replacement surgery.
Range of motion tested at 40 to 105 degrees. Most patients had pain with range of motion beyond 90 degrees. These patients all required revision surgery.
Surgeons found loosening of the tibial component with gross motion of the implant between the tibial tray and the cement of the bone. In all cases, the tibia had debonded and was easily separated from the cement intended to hold the implant securely in place. As the glue failed, the tibial component was loosened, destabilizing the entire knee replacement.
What Recourse Do ATTUNE® Knee Replacement Patients Have?
DePuy Synthes, manufacturer of ATTUNE® total knee replacement system, markets the systems as patented technologies that give patients the confidence of a stable knee replacement and improved range of motion. However, the company has filed dozens of reports with the U.S. Food and Drug Administration (FDA) concerning premature failure of the ATTUNE® total knee system.
Symptoms of ATTUNE Total Knee Replacement Failure
Thousands of patients have been implanted with the ATTUNE® total knee replacement system. Symptoms of premature failure of the system include:
- Persistent pain
- Loosening and instability
- Unusual swelling
- Decreased range of motion
In most cases, the only medical solution is to undergo revision surgery to have the implant removed and replaced. Revision surgery is often more invasive and painful than initial knee replacement surgery, and poses risks for the patient.
The Right to Compensation
A patient who has suffered implant-related injuries caused by design or manufacturing defects in a medical device has a right to bring a lawsuit against the manufacturer. The first lawsuit involving premature failure of the ATTUNE® total knee replacement system was filed against the manufacturer in September, 2017.
If you are experiencing symptoms of device failure after ATTUNE® total knee replacement, speak with an attorney as soon as possible to find out if you have a claim. A knowledgeable attorney is important in evaluating your claim, assessing the full extent of your injuries, and protecting your right to fair compensation for all damages.
Types of Damages in a Lawsuit for a Failed ATTUNE® Total Knee Replacement
Damages you may be eligible to claim may include:
- Pain and suffering
- Lost wages
- Cost of care
- Cost of revision surgery
- Other losses
Top Legal Representation for Defective Medical Device Injuries
A large corporation with a team of attorneys can be a formidable, well-funded legal adversary. At Meyers & Flowers, our seasoned litigators have conducted many successful trials and are not intimidated by the size or experience of the defense team. Our winning team of knowledgeable trial lawyers can handle any case against any opponent.
Medical Device Recalls
Manufacturers of medical products and devices have a responsibility to ensure that their products are safe and perform as they should. Unfortunately, people are injured every day because they have failed to do so. The FDA publishes an ongoing yearly list of Class I medical device recalls. These are medical devices that were recalled because their use may cause serious injuries or death.
Injuries caused by defective medical products and devices can have a huge negative impact on a person’s life. We are here to help you pursue the compensation you deserve after being injured by a defective medical product or device, including the ATTUNE® total knee replacement system.
- Journal of Knee Surgery: Unusually High Rate of Early Failure of Tibial Component in ATTUNE Total Knee Arthroplasty System at Implant -- Cement Interface
- FDA: 2017 Medical Device Recalls