China's MicroPort earned the FDA's most serious designation over a recall of devices used in hip joint replacement surgery after reports surfaced that showed the products could be endangering patients' lives.
The Shanghai-based company's MicroPort Orthopedics' Profemur Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck devices, which replace damaged portions of the hip joint during surgery, could fracture following a procedure and cause symptoms such as sudden pain, instability and difficulty walking, the FDA said in a statement. Taking that all into account, the agency is slapping the recall with a Class I`, which it usually reserves for problems with devices that could result in serious injury or death.
The FDA said that in August, MicroPort sent a letter to distributors and hospital staff that it would voluntarily recall the devices. The company asked healthcare professionals to review the notice, locate all the product mentioned in the letter, stop using or distributing the devices and return the recalled product to its Arlington, TX-based distribution center.
Meanwhile, patients 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 said in its notice.
MicroPort is not the only company dealing with hip implant-related woes. In February, device magnate Johnson & Johnson ($JNJ) said it would add $420 million to its $2.5 billion legal stockpile to resolve claims over recalled hip implants. By the time everything is said and done, J&J will probably pay more than $4 billion to resolve its implant cases, Carl Tobias, a product-liability law professor at Virginia's University of Richmond, said at the time.
In June, U.K. orthopedics giant Smith & Nephew ($SNN) said it would pull 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. But the company doesn't expect the move to impact its 2015 guidance, it said at the time, as the products only comprised about 1% of its global hip implant revenue in 2014.
- read the FDA recall notice