The goal of a full or partial knee replacement procedure is to gain mobility. Patients opt to replace their natural worn-out knee joints with artificial devices because it is supposed to make their quality of life better once they recover from the procedure. Unfortunately, many Depuy knee replacement recipients found the opposite to be true, and the problems they experienced following their knee replacement procedures were far worse than those they dealt with before the procedure.
To avoid medical complications, the FDA has requirements in place intended to reduce the need for revision surgery after a knee replacement device is put in place. All parts are supposed to undergo thorough testing and any concerns about those parts should be reported to the FDA and/or repaired before patients receive the devices. If issues are discovered after a device is in use, knee replacement device manufacturers are supposed to make every effort to fix the problem and alert consumers.
Unfortunately, the FDA system is not full-proof and regulations fail in many cases because the agency does not require similar parts to undergo as vigorous a testing procedure as original parts. So if a replacement device is similar in size, shape, function, or design, or any of its components are, it is exempt from testing.
This “loophole” has resulted in a number of issues with Depuy knee replacement devices and within the last few years, the company recalled several of its products from the market, including knee replacement components.
According to the FDA, the company failed to seek approval before offering its high-flex replacement components to patients, claiming it assumed it would receive approval because the parts were similar in nature to other Depuy devices. The FDA eventually determined the design was not similar enough to previously approved devices and the company should have tested the device and submitted the results for approval.
Knee Replacement Side Effects and Risks
Most people understand knee replacement procedures, and all types of surgery, carry some risk. In the case of joint replacement, revision or follow-up procedures are sometimes needed, especially in younger patients that need to use their devices longer. Issues such as weight and activity level can also play a role.
Some of the more common issues that can be expected with knee replacement devices include:
- Loosening of the implant device
- Shifting of the components
- Decreased range of motion
- Cracks, fractures, and other component failures
- Lengthening or shortening of the leg
- Fractures of the femur or tibia
- Tibial subsidence (this occurs when the implant sinks into soft tissue of the bone in the tibia)
These risks are present in all knee replacement procedures, regardless of the device. However, some newer implants are considered controversial because they have not been subjected to the same rigorous testing as their older counterparts. Many recipients of Depuy’s knee replacement devices and many in the medical community have found the newer devices to be less durable and unable to provide the same range of motion. These devices are also known to loosen more frequently than other options. Depuy and the FDA have both received numerous complaints related to knee replacement devices.
Risks of Revision Surgery
Though it might seem simple enough to repair problems with failing knee replacement devices, the revision procedures are actually quite complicated and feature greater risks than the original surgeries. This is due in part to the fact that Depuy’s high-flex knee implant design requires more of the natural bone to be shaved in order to gain more range of motion after surgery. This increases the risk for revision surgery and means that if revisions are necessary, more bone must be cut away, leaving a patient with significant bone loss.
There was a recall issued by the FDA for Depuy’s Limb Preservation System device in 2013 after reports of numerous instances of a need for revision surgery. One of the primary issues with Depuy’s device was the sleeve component known as the Limb Preservation System. The FDA found the system lacked the structural integrity to support everyday activities, such as walking, standing, or kneeling.
Following implantation of the Limb Preservation System, patients reported fractures, loosening of implants, and the need for follow-up procedures to correct the problems.
Our goal is to ensure people make informed decisions about their health care, especially when it comes to joint replacement procedures. Knee replacement devices can help you improve your quality of life, but there are also many risks involved. If you or a loved one was injured by a Depuy replacement device manufactured between 2008 and 2012, you may be owed compensation for damages.