The DePuyOrthopaedics Synthes Attune knee replacement systems have come under scrutiny as evidence indicates that the device may have adhesion issues and complaints from patients roll in. There are multiple reasons why hip and knee implants fail; however, a major culprit in the malfunction of Attune knees seems to be something technically referred to as “tibial baseplate failure,” or “de-bonding,” This means that the artificial knee becomes unglued from a patient’s lower leg.
National law firm Parker Waichman LLP has extensive experience and success in medical device litigation, including defective knee replacements. Parker Waichman LLP is investigating potential lawsuits on behalf of patients who have been implanted with the DePuy Attune knee replacement device. The firm’s attorneys are available to answer legal questions from individuals seeking information for a potential lawsuit.
Study: HIGH RATE OF PREMATURE attune FAILURE
DePuy Synthes’ Attune total knee arthroplasty system has been tied to an “unusually high” rate of early failure related to its tibial components, according to a new study published in the September 2017 issue of the Journal of Knee Surgery.
The researchers reviewed various U.S. Food and Drug Administration (FDA) reports to its Manufacturer and User Facility Device Experience (MAUDE) database concerning the Attune knee system. A search of the MAUDE system found 232 reports related to the Attune. Researchers said they reviewed clinical, radiographic and intraoperative findings for patients who were implanted with the Attune system and later required revision surgery, according to Mass Device.
Three hospital databases were reviewed for patients who were diagnosed with tibial loosening at the implant-cement interface. A total of 15 cases were reported, according to Mass Device. “Patients presented with pain on weight bearing, effusion and decreased range of motion (ROM) within two years after surgery. Radiographic evaluation demonstrated loosening of the tibial components in two of 15 knees. This included cruciate retaining, posterior stabilized, fixed bearing and rotating platform bearing designs,” study authors wrote. “Intraoperative findings demonstrated gross loosening of the tibial component at the implant-cement interface.”
Researchers pointed out that there were 21 reports of tibial loosening at the implant-cement interface to MAUDE in the prior two months, with “numerous other tibial failures” also reported without the mechanism for failure specified. The study authors wrote that, “We believe that this complication is underreported due to failure of radiographs to assess loosening. In addition, MAUDE database reporting is not consistent and competing companies cannot provide data on the revised components. In patients who have negative workup for a painful joint, one must consider the diagnosis of debonding.”
The most commonly seen adverse reactions associated with Attune failure, included loss of or failure to bond; component(s) wearing down; fracture; loss of osseointegration (direct structural and functional connection between ordered, living bone and the surface of a load-carrying implant); and metal components shedding debris, which may lead to metallosis (metal poisoning).
The issue has led to at least one lawsuit filed over the Attune device, alleging premature failure and citing the published research in the Journal of Knee Surgery.
potential Attune adverse events
Loosening and debonding of the tibial baseplate or tray generally leads to pain, swelling, inflammation, infection, and instability. These symptoms typically revision surgery. Patient suffering from an allegedly defective DePuy Synthes Attune knee replacement may experience knee instability when standing or bearing weight or attempting to move the knee backward or sideways, which may cause ligament inflammation and damage; decreased range of motion; heat, which is normal for several months following surgery, but is a warning sign if persistent; swelling when the knee lining becomes inflamed, which will likely cause fluid to accumulate, resulting in swelling; and persistent, throbbing pain.
PAINFUL REVISION SURGERY
Premature device failure may lead to painful revision surgery and extensive rehabilitation and physical therapy. Revision surgery is generally more difficult than the initial surgery, especially when bone loss has developed due to the implanted device.
When a defective Attune device was removed and replaced, a procedure known as revision surgery, some surgeons revealed that they saw no sign that cement or bone had ever adhered to the implant. A typical reason for knee implant failure, noted by surgeons who perform revision surgeries, appears to occur when the knee device does not adhere to the bone due to the lack of bonding between the bone and the implant. Some surgeons described the removed metal tibial insert as free from any bond, basically appearing to be in the same condition as it did when the device was removed from the sterile packaging and before implantation. There was never any adhesion and the cement had failed.
Revisions surgery is often more difficult than the initial surgery, especially when bone loss has developed as a result of the implanted device. When painful revision surgery is needed when the DePuy Attune fails, extensive rehabilitation may be necessary. Revision surgery is typically more complex, dangerous, painful, and costlier than initial implant surgery.
KNEE REPLACEMENT INFORMATION
Total knee systems are comprised of several different parts, which mimic the anatomy of the knee, the body’s largest joint. It is made up of the lower end of the thighbone (femur), the upper end of the shinbone (tibia), and the kneecap (patella). Cartilage covers the area where these three bones meet, providing protection and reducing friction. Two c-shaped wedges called menisci are located between the femur and the tibia to provide a shock-absorbing cushion.
During total knee replacement, surgeons remove damaged cartilage and bone from the ends of the femur and tibia and replace these parts with metal components. A plastic spacer is then inserted between the two metal components to create a smooth, frictionless surface. In some cases, it is also necessary to replace the patella with a plastic component.
PREVIOUS ATTUNE KNEE REPLACEMENT ISSUES
In June 2015, the FDA recalled DePuy’s Tibial Articulation Surface Instrument. This is a device used during knee replacement surgery to ensure proper placement of the tibia. A small coil that is part of the instrument could become detached and remain inside the patient’s body. This has been compared to a sponge being left behind in a patient when a surgical incision is closed.
DePuy Orthopaedics, a subsidiary of Johnson & Johnson, and the parent company of DePuy Synthes, has also been involved in litigation concerning hip implants. In December 2016, a federal jury in Dallas, returned a combined verdict of over $1 billion on behalf of six people who suffered serious medical complications due to defective metal-on-metal hip implants.
In spite of these complications, Johnson & Johnson, DePuy Orthopaedics, and DePuy Synthes products continue to be available on the market. The DePuy Synthes Attune knee replacement device has not yet been recalled, nor have any lawsuits been filed, to date.
HAVE YOU BEEN INJURED BY A DEPUY KNEE IMPLANT DEVICE?
If you or someone you know has sustained injury involving a DePuy knee implant, you may be eligible for valuable compensation. The Parker Waichman personal injury law firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529)
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