The U.S. Food and Drug Administration (FDA) has issued a Class I recall of devices used in hip joint replacement surgery after reports surfaced that showed the products could endanger patients' lives.
The Profemur Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck devices, made by Shanghai, China-based MicroPort Orthopedics, could fracture after a procedure, causing patients sudden pain, instability and difficulty walking, the FDA said in a statement made public only a few days ago. The device is used to replace damaged portions of the hip joint during surgery. "An acute fracture will require revision surgery to remove and replace the neck and stem components. Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, and even death," the FDA notice reads.
MicroPort sent a letter to distributors and hospital staff in August notifying them of the voluntary recall. The company advised healthcare professionals to review the notice, locate all affected product, discontinue distribution and use of the devices and return the recalled product to its Arlington, Texas-based distribution center.
Meanwhile, patients already implanted with the devices should continue to follow-up with their doctors as prescribed by their surgeon, and should seek treatment immediately if they experience any sudden onset of severe hip pain, difficulty walking, trauma to the hip or leg, or tingling or loss of feeling in their leg, the FDA notice said.
MicroPort's recall is the latest in a string of hip implant-related woes among orthopedic firms this year. In February, Johnson & Johnson added $420 million to its $2.5 billion legal stockpile to resolve claims over recalled hip implants.
Then in June, United Kingdom orthopedics behemoth Smith & Nephew plc pulled some hip implant sizes and related components from the market after data from the U.K.'s cost-effectiveness watchdog found that smaller sizes of the system had higher revision rates than expected. The company does not expect the move to impact its 2015 guidance, as the products only comprised about 1 percent of its global hip implant revenue in 2014.