The attorneys at Franklin D. Azar and Associates are investigating problems with the materials used in the Depuy Synthes Attune device. The Depuy Attune knee was first cleared by the FDA in 2010, and Depuy began selling the device in 2013. Since then, there have been a significant number of adverse events reported to the FDA associated with this device. Specifically, the medical community has noted the tendency of the tibial component of this device to fail to properly adhere to the bone cement used in the procedure. This problem was first documented in a 2017 article in the Journal of Knee Surgery. Depuy has denied these problems, but curiously has adopted changes to the design of the tibial component of this system to improve its ability to bond to cement.
Knee Replacement Surgery – A History of Clinical Success
Since the first knee replacement procedure was performed in the late 1960s, knee replacement surgery has become quite common in the United States. The human knee is the largest joint in the body, and having healthy knees is required to perform most tasks associated with daily living. It is estimated that more than 600,000 Americans undergo knee replacement surgery each year. The most common reason knee replacement surgery is performed is chronic pain, usually due to arthritis (Osteoarthritis, Rheumatoid Arthritis, or Post-Traumatic Arthritis). Total knee replacement systems are comprised of several different parts, which are designed to mimic the anatomy of the human knee. The knee is made up of several parts: 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 and provides stability and protection. During a total knee replacement procedure, surgeons remove the damaged cartilage and bone from the ends of the femur and tibia and replace these parts with metal pieces. A plastic spacer is then inserted between the two metal pieces to create a smooth, frictionless surface. Since the inception of knee replacement surgery in the 1960s, improvements in surgical materials and techniques have greatly increased the effectiveness of knee replacement surgery. Knee replacement surgery is considered one of the most successful types of surgery in all of medicine.
Study Shows High Rate of Premature Failure Due to Failure of Tibial Component to Bond to Cement
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 who conducted the study said they reviewed clinical, radiographic and intraoperative findings for patients who were implanted with the Attune system and later required revision surgery. Additionally three hospital databases were reviewed for patients who were diagnosed with tibial loosening at the implant-cement interface. “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.
Symptoms of Tibial Loosening
Loosening and debonding of the tibial component of the Depuy Attune knee system is generally associated with the following side effects:
Tibial Loosening Leads to the Need for More Surgery
If you are a patient who has experienced tibial debonding, you may develop the need for additional surgery to try and fix the problem. Revision surgery is painful, expensive and requires additional physical therapy and rehabilitation. Patients can also experience complications such as bone loss when the need for revision surgery arises. Some surgeons have reported that when performing a revision surgery on patients implanted with Depuy Attune knees, they saw no sign whatsoever that the cement had ever adhered to the implant. Surgeons have described the explanted components of the Depuy Attune as looking like they did before the device was implanted, with no cement present on the device at all.
A History of Problems with the Depuy Devices
The issue of tibial debonding is not the first safety issue to have arisen regarding this Depuy Attune device. In June 2015 the FDA issued a recall on Depuy’s Tibial Articulation Surface Instrument. This is a tool that helps the surgeon properly place the device during implant surgery. The reason for the recall was that a small coil that is part of this tool could become detached during implantation surgery and could be left in the patient’s body.
Depuy, a subsidiary of Johnson and Johnson, has also faced a myriad of lawsuits involving another of its prosthetic joints. More than 9,000 cases are pending in the Northern District of Texas in MDL 2244, In Re: Depuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation. To date, there have been four bellwether, or “test trials” in MDL 2244, with the most recent trial ending in a $247 Million dollar verdict in favor of six plaintiffs in November 2017. This verdict was the third consecutive big win for the plaintiffs, who also secured a $502 million verdict in January 2016 and a $1 billion verdict in December 2016.