Patients expected their Profemur artificial hips to last, but when they snapped in half, hundreds of them were left in agony, unable to walk, and requiring further, unnecessary and painful surgery, according to numerous ongoing – and previous, settled-out-of-court – cases in the USA.
Bradley Little, a PE teacher, was walking through a school hallway in 2017 when he collapsed. He thought he was having a stroke. Or had been shot. He tried to stand, but his leg wouldn’t move.
An X-ray revealed that the artificial hip implant in his right leg had “suddenly and catastrophically structurally failed”, according to a lawsuit he later filed.
The implant severed at its “neck”: the 5cm or so-long titanium part linking Little’s thigh to his torso, reports CBS News.
Profemur artificial hips were once considered innovative for a feature known as “dual modular necks”, intended to modernise total hip replacement surgery.
Devices are expected to last at least 20 years, according to the American College of Rheumatology.
The Profemur necks, available in various lengths and angles, made it easier to customise the hip implants for patients.
But the neck also proved to be a weak point: over the past two decades, more than 750 Profemur hips like Little’s have fractured at the neck, an attorney for the manufacturer has said in court.
Patients were left unable to walk and needing emergency surgery. Reports submitted to the FDA describe them stranded in the midst of routine life, while hiking, golfing, mowing the lawn, getting out of a chair, bending to pick up a key.
After each break, patients endure hours-long repair surgery that can be traumatic because the broken implant is embedded in their bone and difficult to remove, said three orthopaedic surgeons who’ve performed these procedures.
The repair surgery, which can cost tens of thousands of dollars, often requires a patient’s femur to be cracked open to extract a metal stem that had been inserted down its length. Lawsuits have likened removing the bone around the stem to peeling a banana.
Many Profemur fractures in patients’ bodies could have been avoided if the manufacturer or the FDA had responded to early signs of failure with more urgency, according to a months-long investigation by KFF Health News and CBS News.
An FDA database shows reports of Profemur’s titanium modular necks breaking inside US patients since at least 2005, but the corresponding parts were not recalled until 15 years later, if at all.
Ten sizes of the titanium neck were eventually recalled in 2020 after being identified in more than 650 reports of fractures submitted to the FDA.
Six other sizes of titanium necks, identified in about 75 additional fracture reports, have not been permanently recalled.
In 2009, Profemur’s original manufacturer, Wright Medical Technology, switched the metal of the modular neck from titanium to a stronger cobalt-chromium alloy. Then, after some of those necks also began to break, the company recalled one size but left 11 others on the market, despite reports of corrosion causing the implants to fail.
In total, at least 28 sizes of the Profemur artificial hips with a dual modular neck have allegedly fractured or corroded, but just 11 sizes have been permanently recalled, show FDA data and records.
Wright Medical, a Tennessee company founded in 1950, has made implantable medical devices since at least the 1970s. It sold its hip and knee implant division, including the Profemur, to Chinese company MicroPort for $285m in 2013.
Stryker Corp, one of the nation’s largest device companies, paid about $4bn for the rest of Wright in 2020.
Wright Medical declined to comment, while MicroPort did not respond to more than a dozen requests for comment. It still advertises Profemur hip implants with dual modular necks on its website, where the devices are listed as “not marketed/registered in the United States”.
The FDA did not answer questions about why some Profemur sizes were not permanently recalled. FDA spokesperson Audra Harrison said device manufacturers are largely responsible for deciding which products to recall and when to do so, while the agency “monitors” this process and requests recalls only in “urgent situations”.
In the case of the Profemur modular necks, all recalls were initiated by MicroPort, and the FDA “took action accordingly”, Harrison said.
Most lawsuits have been resolved through out-of-court settlements without Wright Medical or MicroPort publicly admitting fault, show court filings. The remainder of the lawsuits are ongoing.
Wright Medical has denied liability in some lawsuits before settling them and has defended Profemur implants in court in the years before some of the implants were recalled for fracturing.
“A device fracture does not mean it is defective,” Wright Medical attorney Tiffany Carpenter said in court in 2018. “Devices fracture all the time.”
Collectively, the lawsuits allege that Profemur artificial hips broke or corroded at the neck in about 7½ years, on average. Profemur necks made from titanium broke on average in about 10 years while necks made from the cobalt-chromium alloy broke or corroded in just six years.
It is not publicly known how many Profemur hips have failed.
Peer-reviewed studies estimate fracture rates as low as 1% and as high as 6% for some Profemur models.
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