Summary: A recent investigation by KFF Health News and CBS News reveals concerning issues with Profemur artificial hip implants, once lauded for their innovative dual modular necks. These necks, designed to enhance customization in total hip replacement surgeries, have become a significant liability, causing over 750 fractures over the past two decades.
Patients experiencing these fractures endure traumatic repair surgeries, often costing tens of thousands of dollars, with the broken implant embedded in the bone, making removal challenging. The fractures have occurred during routine activities, leaving individuals stranded and necessitating emergency surgery.
Despite early signs of failure reported to the FDA since 2005, the corresponding parts were only recalled 15 years later in 2020. Some sizes remain unreclaimed, raising concerns about patient safety. The manufacturer, Wright Medical Technology, switched the modular neck’s metal from titanium to a stronger cobalt-chromium alloy in 2009. However, fractures continued, leading to recalls of certain sizes but leaving others on the market.
Wright Medical sold its hip and knee implant division, including Profemur, to MicroPort in 2013. The FDA, responsible for monitoring recalls, contends that manufacturers largely decide when to recall products. Lawsuits filed over the past decade have alleged severe pain, lack of mobility, and neurological issues due to metal ions leaking into the bloodstream.
The investigation highlights discrepancies in reported fracture rates, with estimates ranging from 0.2% to 6%, and ongoing lawsuits revealing the profound impact on patients’ lives. Despite knowledge of issues dating back to 2000, the manufacturer continued marketing Profemur as a reliable solution, even engaging tennis legend Jimmy Connors as a spokesperson.
The report concludes with the challenges posed by the implant’s dual modular neck, originally developed by a European company and later introduced in the U.S. by Wright Medical in 2000. Experts argue that the additional junction in the neck, intended for improved customization, became a weak point prone to fractures, causing severe complications for patients and raising questions about the FDA’s approval process.