More than 98% of patients who undergo total knee replacement surgery are 45 or older. The procedure is most common for people 65 and older. However, younger people make up an increasing percentage of knee replacement patients.
The average age for Exactech Knee Recall Lawsuit patients dropped significantly from 2000 to 2010. (9) Knee replacement surgeries performed on people aged 45-64 tripled from 1999 to 2008.
Most knee replacements only last a decade or two before wearing out. This means these younger knee replacement patients are likely to “outlive” their devices and will eventually require revision surgery to replace them.
How Many Knee Replacements Are Done Each Year?
More than 750,000 people had knee replacement surgery in 2014 according to data from the Healthcare Cost and Utilization Project. Researchers project the number of knee replacement procedures will increase to 1.26 million by 2030 as baby boomers continue to age.
When Do Companies Recall an Implant?
When a company discovers a problem with a device, it needs to issue a recall. According to the FDA, “recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.”
Manufacturers have issued recalls for a number of knee replacement devices, including:
Arthrex iBalance Total Knee Arthroplasty
Smith & Nephew Journey BCS Knee Replacement
In 2015 and 2016, Arthrex, Inc. instituted recalls of the iBalance tibial tray because of tibial baseplate loosening. The trays were manufactured with a smooth surface that may have resulted in poor bonding between the tray and the knee.
Five years after stopping production, Smith & Nephew issued a recall of its first-generation Journey BCS Knee in 2018. The manufacturer cited “a revision rate over 1.5 times” the average as the reason for the recall.
FDA Class 2 Recalls
All of these recalls were categorized as Class 2 by the FDA. Class 2 means a product “may cause a temporary or reversible health problem” or has a slight chance of causing “serious health problems or death”
The FDA medical device recall database contains the most up-to-date information about recalls of knee implants and other devices.
Unfortunately, some people experience severe health problems following knee replacement surgery. ABC News reported on a woman whose knee implant left her in “constant pain, 24/7,” and too disabled to work.She’s not alone: an estimated one-third of patients with knee replacements continue to experience chronic pain following the procedure.