FDA Class 1 Recall for MicroPort Hip Replacement DeviceOct 9, 2015
The Food and Drug Administration (FDA) has assigned its most serious device recall designation to the recall of China's MicroPort replacement hip joint.
The MicroPort Orthopedics' Profemur Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck device is under Class 1 recall because it could endanger patients' lives, 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. 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, 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 says, which is why the agency categorized this as a Class 1 recall.
The recall was initiated in August, and all lots of the hip device manufactured between June 15, 2009 and July 22, 2015 are affected. The 10,825 recalled replacement hips were distributed from June 15, 2009 to July 31, 2015.
In August, MicroPort sent a letter to distributors and hospitals 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.
The FDA advises patients who have the devices to continue regular follow-up as recommended by their surgeons, and to seek immediate treatment if they experience sudden onset of severe hip pain, difficulty walking, trauma to the hip or leg, or tingling or loss of feeling in the leg.
A number of manufacturers of hip replacement devices 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 it 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 will likely end up paying more than $4 billion to resolve its hip implant cases. In June, Smith & Nephew, a U.K. orthopedic-device giant, said it would pull from the market some sizes of hip implants and related components after data from the U.K.'s cost-effectiveness watchdog showed that smaller sizes of the hip device had higher revision rates than expected.