The MicroPort Orthopedics’ Profemur Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck device is under Class 1 recall from the Food and Drug Administration (FDA).
The FDA has assigned Class 1—its most serious device recall designation—to the recall of the MicroPort replacement hip joint, FierceMedicalDevices reports. MicroPort Orthopedics Inc. has received reports of an unexpected rate of fractures after surgery related to this specific modular neck.
The Profemur Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck devices, which are implanted to replace damaged portions of a patient’s hip joint, could fracture after implantation. If the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking and performing common tasks, the FDA said in the recall announcement.
According to the FDA, when there is an acute fracture, the patient will require revision surgery to remove and replace the neck and stem components. Acute fracture and emergency revision surgery constitutes a “serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, and even death,” the FDA says, and this is why the agency classified the recall as Class 1.
The recall was initiated in August 2015. All lots of the hip device manufactured between June 15, 2009 and July 22, 2015 are affected, with 10,825 devices recalled. The recalled hips were distributed from June 15, 2009 to July 31, 2015.
MicroPort wrote to distributors and hospitals in August announcing the recall of the devices. The company asked health care professionals to stop using or distributing the devices and return any of the recalled hips in their inventory to the Arlington, Texas distribution center, according to FierceMedicalDevices.
For patients who have MicroPort hips, the FDA advises them to continue all follow-ups recommended by their surgeon. Any patient who experiences sudden onset of severe hip pain, difficulty walking, trauma to the hip or leg, or tingling or loss of feeling in the leg should seek immediate medical attention.
MicroPort is not the only manufacturer of hip replacement devices experiencing difficulties. Two of the largest producers of hip replacement devices—Johnson & Johnson and Smith and Nephew—are dealing with legal claims and device recalls, according to FierceMedicalDevices. In February of this year, Johnson & Johnson said it would add $420 million to the $2.5 billion fund established to resolve claims over recalled hip implants from its DePuy Orthopaedics unit. Carl Tobias, a product-liability law professor at Virginia’s University of Richmond, said J&J could end up paying more than $4 billion to settle all of the hip implant cases. Smith & Nephew, the U.K.’s orthopedic-device giant, announced in June that it was removing some sizes of hip implants and related components from the market after data from a U.K. watchdog showed that smaller sizes of the hip device had higher revision rates than expected.