Unfortunately, there are also many instances in which knee replacement devices malfunction and patients are forced to undergo risky revision surgery.
Is knee replacement surgery a safe procedure and should you consider undergoing the procedure if your doctor suggests it?
In order to decide, you must be aware of the most up-to-date safety information concerning knee replacement devices.
Are Knee Replacements Safe?
There are approximately 600,000 knee replacement surgeries performed annually in the United States, and estimates show that in the next 10 to 15 years, this number will be in the multi-millions, due in part to the aging Baby Boomer population. But older adults are not the only ones to receive knee replacement devices. Thousands of middle-aged and younger adults receive knee replacements every year and because these devices must perform for more years, there is a higher likelihood revision surgery will be needed.
In addition to the length of time knee replacements must function, some of these devices were initially defective.
Knee Replacement Recalls
Zimmer recalled 11,000 if its Persona Knee implants in 2015 after the devices failed and the company is currently negotiating with recipients of the devices who were affected.
The German manufacturer B. Braun is facing more than two dozen lawsuits filed in 2017 concerning its ceramic knee replacement device. Recipients claim their devices loosened because the cement used in the implantation procedure failed.
These are just two examples of the numerous knee replacement devices that failed and caused recipients to experience pain and a need for follow-up procedures. The majority of recipients who have taken legal action against knee replacement device manufacturers have experienced loosening of their device, a need to undergo revision or repair surgery, or a combination of these outcomes.
In addition to Zimmer and B. Braun, a number of other knee replacement manufacturers have recalled devices or been involved in legal action related to their products. These manufacturers include Wright, DePuy, Exactech, and Arthrex. Each of these manufacturers had multiple models and/or components that were the subject of a recall or public health alert.
How Long Do Knee Replacement Devices Last?
In general, joint replacement devices, including knee replacements, are designed to last about 15 years. For older adults, this is an acceptable period of time. But when a person receives an implant before he or she is 70 years old, there is a high risk of failure.
Making matters more complicated, many of the devices on the market have not even lasted the predicted 15 years.
A study by the American Academy of Orthopaedic Surgeons conducted in 2010 found that Zimmer implants have a more than 30 percent failure rating and recipients needed to undergo revision surgery.
Another study found that DePuy (a division of Johnson & Johnson) knee replacement devices had a failure rate of 49 percent within six years. The company had previously reported only a 13 percent failure rate.
In addition to the general failure of their implants, knee replacement device manufacturers have also been accused of making false claims, selling a product that was known to be defective, and failing to warn patients of the defects and possible consequences.
Some in the medical community believe the problem with knee replacement devices is linked to the approval process. Many of the products on the market were approved by the US Food and Drug Administration without much testing because they were similar to other products already on the market. Critics believe the agency’s 510(k) process that allows for speedy approval has led to an increased failure rate of knee replacement devices.
Anyone undergoing knee replacement surgery needs to explore their options carefully and discuss the risks with their doctors before proceeding.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.