Knee Replacement Lawyers
DePuy Synthes Attune®
Knee arthroplasty, more commonly known as knee replacement, is a surgical procedure in which the weight-bearing surfaces of the knee joint are replaced in an effort to relieve pain and disability. A knee replacement procedure can be partial or total and typically entails replacing the damaged or diseased knee joint surfaces with metal or plastic components.
There are a number of reasons for which a knee replacement may be performed, most commonly for osteoarthritis. However, knee replacement surgery is also common to relieve the debilitating pain caused by cartilage defects, meniscus tears and ligament tears.
According to the American Academy of Orthopedic Surgeons, the majority of knee replacement surgeries have a positive outcome. Most people return to their daily activities are able to stay active[1].
However, in situations where the knee replacement system used is defective, the patient may be required to undergo additional surgeries. Often times these revision surgeries are more painful and require a longer recovery period than the original procedure. One such situation may be the DePuy Synthes Attune® Kneed Replacement System, which was the focus of a June 2017 study published in The Journal of Knee Surgery.
DePuy Synthes Attune® Knee Replacement System Complications
The Journal of Knee Surgery study, titled “Unusually High Rate of Early Failure of Tibial Component in ATTUNE Total Knee Arthroplasty System at Implant-Cement Interface”[2] was prompted after a high rate of debonding of the tibial implant-cement interface was observed.
The study followed 15 patient cases, all of which experienced pain when bearing weight, effusion, and suffered a decreased range of motion with in 2 years of surgery. The study also reviewed the Manufacturer and User Facility Device Experience database (MAUDE) and found 21 reports of tibial loosening at the implant-cement interface associated with the Attune knee replacement system. Additionally, the authors of the study believe that the loosening associated with the DePuy Synthes Attune® knee replacement system are under reported as x-rays alone may not be able to identify the failure. In each case followed, patients were required to undergo a revision surgery to repair the issue.
Defective Design and Knee Implant Loosening
There are a few reasons why a knee replacement system can fail, one of which is defective design. When a medical device like a knee replacement system fails, or does not operate as designed, patients can experience painful complications. Often times doctors and patients are not aware of issues with the device until after implantation. The FDA tracks reports of complications resulting from medical devices in the FDA Adverse Event Reporting System (FAERS). If there are enough reports associated with a particular device or one of its components the medical device may be recalled.
The most common failure of the DePuy Synthes Attune® knee replacement system is tibial plate loosening. The tibial plate is the component part of the artificial knee joint that makes up the top of the lower leg bone. Loosening of the tibial plate can result in instability and pain in the joint, and most often requires revision surgery to replace all or part of the artificial knee joint.
