Knee replacement surgery is not uncommon and many people have received an artificial joint or parts of an artificial knee because of damage from arthritis, injuries, and other conditions. The replacement of the damaged knee joint with an artificial system can help a patient to get better mobility and to reduce pain. For most patients the surgery goes well and the new knee is a success.
For some, though, the artificial joint turns out to be problematic and to cause more pain as well as complications like bone damage and loss, and joint instability, not to mention the need for revision surgeries. Some of the joints that have caused these problems were considered to be faulty and were the subject of voluntary knee replacement recalls. DePuy and Zimmer are two companies that have recalled knees. If you have received a knee that was ultimately recalled, you have rights and you should be aware of what steps you need to take next.
Knee Replacement Surgery
A knee replacement is typically done for a patient who experiences enough pain and lack of mobility to make the risks of surgery worthwhile. Arthritis and other conditions can cause enough damage to the joint over time that it becomes too painful to move very much and this can lead to a significant decrease in the quality of life. A knee replacement can completely turn that around if it goes well, and for most patients it does.
Knee replacements surgeries may be complete or partial, depending on the extent of the damage to the natural joint. Artificial knees may include the whole joint or only components depending on what the patient needs, and may be made of ceramic, metal, or plastic. Artificial knees may also have a fixed or rotating platform. The latter gives more natural movement to the joint.
DePuy Knee Replacement Recalls
One of the companies that makes artificial knee systems and one that has faced recalls is DePuy. The recall came after a warning letter from the U.S. Food and Drug Administration (FDA) in 2011. The agency accused DePuy of marketing and distributing products that had not yet been approved. Some of the artificial knees and other products made by the company had been redesigned and released without approval from the FDA.
In 2013 DePuy faced another recall when the FDA issued another warning. This time the issue was over the safety of a component of the DePuy Limb Preservation System, or LPS. This system included a component called the Diaphyseal Sleeve, which was found to be faulty. The Sleeve is used in knee revision surgeries as a part of the reconstruction of tissue and bone that has been damaged. The sleeve is inserted into the leg bone to support the reconstruction, but the FDA found that DePuy’s Diaphyseal Sleeve was inadequate to support the load put on it and it had to be recalled. The damage it caused in some patients included broken bones, infections, and in some cases even amputation of the leg.
Stryker is another company that makes knee replacement components and tools and it faced a Class I FDA recall in 2013. The product in question was the ShapeMatch Cutting Guide. This was a disposable cutting guide designed to be used just once by a surgeon to guide and mark a bone before cutting it to fit the replacement knee.
The company initiated the recall of its own product because it found that the Cutting Guide did not match up with the parameters that surgeons were entering into the tool’s web application prior to surgery. Surgeons had to manually correct the parameters and this resulted in cutting ranges not approved by the FDA. The result for some patients could have been fractures, pain, limited mobility, instability in the joint, and a need for revision surgeries. The FDA at the time of the recall announcement had received 44 reports of incidents related to the faulty tool.
Zimmer Knee Replacement Recall
In 2015 the FDA announced a Class II recall of a Zimmer knee product, the Persona Trabecular Metal Tibial plate. This is one component of the Persona artificial knee system and was recalled because of reports of adverse events. The complaints included loosening of the plate in the joint and radiolucent lines. The latter are gaps between the artificial knee and the natural bone.
Radiolucent lines can cause serious complications including getting debris lodged in the gap, bone damage, selling and pain, and ultimately failure of the entire artificial knee. Revision surgery is typically needed when radiolucent lines develop. Zimmer initiated a voluntary recall, backed up by the FDA.
What to Do in the Event of a Recall
If you have an artificial knee you should be aware of all recalls in case your knee is the subject of one. In the event of a recall you have certain rights as the patient and recipient of the joint and you need to take steps to ensure your rights are protected. The company that made a faulty, recalled joint has an obligation and responsibility to warn patients that there are problems, and if you were not warned, you may have the right to sue and receive compensation.
Recalls often come with compensation for the patients affected, but you may be entitled to more than what the company is offering. The compensation may fall well short of what you need to cover your additional expenses, not to mention any income you may have lost from being forced to miss work. Your pain and suffering should also be considered, as well as any loss of mobility you experienced from a faulty knee replacement.
If you are facing a recall, make sure you talk with a lawyer to discuss your rights and your options. Get this professional legal advice before you sign anything, as you may be asked to sign away your right to sue for damages. You should also talk to a lawyer before you talk to any representatives from the device manufacturer. Protect your rights first and make sure you get what you deserve.