In March 2015, Zimmer, an Indiana-based company which specializes in artificial joints, surgical products and trauma devices, recalled one of its artificial knee implants, the Persona Trabecular Metal Tibial Plate. The device was recalled due to a higher-than-normal failure rate as well as the development of radiolucent lines and osteolysis by those implanted with the device. Other problems associated with the Persona Trabecular Metal Tibial Plate include: nerve damage, issues with mobility, infection, inflammation, bone fractures and knee instability.
The Cementless Persona Trabecular Metal Tibial Plate
When the components of a knee replacement become separated from the bone, soft tissue or fluid can fill the gaps between the bone and the implant component. Over time, the knee replacement may begin to loosen. In some instances, nerve damage can occur when the tibial plate shifts. The surface of the Persona Trabecular Metal Tibial Plate is porous, in order to encourage in-growth of the surrounding bone, and no cement is used to place the plate.
The cementless components of the Persona have a rough, porous coating, however new bone growth spans only 1-2 mm, therefore the surgeon uses special tools to shape the natural bone to fit tightly to the prosthesis. Using a cementless component requires healthy bones, and it can take as long as three months for the bone material to grow into the new joint component. Because of this, patients with a cementless knee implant component such as the Persona Trabecular Metal Tibial Plate, are usually advised to postpone putting their full weight on the new knee joint for a period of 4-12 weeks.
Complaints Associated with the Zimmer Persona Trabecular Metal Tibial Plate
The Zimmer Persona Trabecular Metal Tibial Plate may have a higher-than-expected rate of loosening due to a lack of appropriate fixation. With more than 11,500 Persona knee implant devices in circulation, there could be many who have sustained injury due to a Persona. At the time of the recall, there were 40 known complaints regarding the Persona. Of those, 16 patients had been forced to undergo revision surgery. The Australian government released a hazard alert which stated that of the WHAT DOES THIS MEAN? complaints received, 36 percent identified symptomatic radiolucent lines. Another 28 percent identified asymptomatic radiolucent lines.
Factors Which Influence Medical Device or Drug Recalls
Unfortunately, many times recalls of a medical device come too late for the consumers who have suffered considerable harm because of the device. Multiple factors influence the recall of a medical device. Sufficient public outcry can prompt the recall of a medical device as can whether or not government regulators—such as the FDA—choose to get involved. Most recall decisions are probably more influenced by economics than anything else. If sales of a medical device or drug are especially profitable, the manufacturer may delay informing the public about potential risks associated with the drug or device.
The manufacturer of the device may also worry that if they admit there is a problem with the device, they are leaving themselves vulnerable to lawsuits. It is not necessary to wait for a recall before exercising one’s legal rights, and those injured by a medical device or drug may be entitled to compensation whether there has been a recall or not. Once the device is recalled, however, the manner in which the injured party responds can affect any legal claims.
Getting the Help You Need When a Knee Replacement Goes Wrong
The American Academy of Orthopedic Surgeons found in 2012 that 4.5 million Americans over the age of 50 have had at least one knee replacement surgery. Artificial knees and hips have become so popular over the past ten years that the number of knee replacements has more than doubled. Those who decide on a knee replacement procedure are trusting the device chosen by their doctor is safe and effective. When that hope turns out not to be true, consumers are entitled to compensation from the manufacturer of the device. If you have suffered injury from a Zimmer Persona Trabecular Metal Tibial Plate, speaking to a knowledgeable attorney can ensure your rights and your future are properly protected.