More than a million people each year undergo knee replacement surgery. As of 2012, at least 4.5 million people had at least one knee replaced. A total or partial knee replacement uses an artificial joint to replace diseased bone and relieve the patient’s pain. Most knee replacement procedures are undertaken to provide relief from the pain caused by arthritis.
Companies Making Total And Partial Knee Replacement Devices
Several manufacturers make knee replacement devices. Each is slightly different because of the material used, the surgical techniques required, the extent of improved range of motion and whether the device is intended for a man or a woman. In addition, different devices are produced for total knee replacement (TKR) and partial knee replacement (PKR).
These companies make most of the knee replacement devices in use today:
- Smith & Nephew
Each company makes several types of knee replacement devices, creating many options for patients seeking increased function and relief from knee pain.
Numerous artificial joints are available to meet a patient’s needs. However, not all of them are appropriate for every patient. Moreover, some devices appear to fail prematurely or have other defects, causing patients even more pain.
Examples Of Problems With Knee Replacement Devices
One of the most common problems with knee replacement devices is failure to bond with the remaining bone. Other problems include rejection of the device, usually because of an allergic reaction to the device’s metal components. Another issue found in knee replacements is leeching, which occurs when the materials in the device move into the body and away from the knee. Still another is that the devices become loose. Other complications include infection, inflammation, bone damage and muscle damage.
The U.S. Food and Drug Administration (FDA) has recalled several knee replacement devices for problems such as these. In 2008, the FDA recalled the DePuy LCS Knee Implant-Meniscal device because of sizing errors. The FDA also warned DePuy that another of its knee replacement devices, the PF Sigma Knee Systems device, had not received the approvals needed to make it usable in the U.S. DePuy recalled the device.
Zimmer Recalls And Lawsuits
More recently, Zimmer voluntarily recalled 11,658 Persona Trabecular Metal Tibial Plate knee implants. The FDA then issued a Class II recall, warning that the device could become loose and result in infections and other complications. The agency issues this level of recall when a manufactured medical product can cause damage that is temporary or that can be reversed with additional surgeries.
The Persona may leave large gaps between the individual parts of the device and the bone, causing joint fluid tissue to accumulate in the spaces. Other problems with the Persona include debris from the device lodging in the cracks that can lead to a condition caused osteolysis. Correcting this problem usually requires additional surgery to replace the implant.
Zimmer has also recalled other knee replacement devices, including the NexGen (2014) and MIS Tibial (2010) because of failure, defective screws and loosening. These two recalls affected almost 110,000 people. Patients injured because they had these devices implanted filed more than 1,000 lawsuits in Illinois. In the first of these lawsuits, the court ruled in favor of the defendant Zimmer, which is based in Indiana.
Stryker Recalls And Lawsuits
Patients have also filed claims against another large device maker, Stryker. One lawsuit, filed in Colorado in 2014, alleged that the Stryker Triathlon Total Knee System caused allergies and that the company had failed to warn of this possible complication. Stryker has also been sued over its Uni-Knees device. The allegations included charges that the devices sold were outdated.
The company has also paid significant fines because it sold a device intended to help surgeons perform knee replacement surgery, known as the ShapeMatch Cutting Guide, without FDA approval. The cutting guide was used to help surgeons implant the Triathlon knee replacement device. The defective cutting guide, which was recalled by the FDA, was alleged to have caused a wide range of complications that included chronic pain, instability, misaligned implanted devices, implant failure and fractures. Patients were forced to undergo revision surgery to replace their devices.
If You Were Injured, Get Help
Both Stryker and Zimmer have also been the subject of lawsuits involving hip replacements and other medical devices. The companies face charges similar to those raised in knee replacement lawsuits. If you were hurt because of a defective implanted medical device, an attorney may be able to advise you.