The FDA said last Friday it is recalling MicroPort Orthopedics ProFemur long cobalt chrome 8 degree Varus and Valgus modular neck implants over issues with the acute fractures.
The federal watchdog labeled the recall as a Class I, the most serious type of recall issued by the FDA, which indicates “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The ProFemur stems are used during total hip replacements to replace damaged portions of the hip joint, with the recalled unit specifically used to serve as a replacement modular neck, according to the FDA.
The FDA said that MicroPort “received reports of an unexpected rate of fractures after surgery related to this specific modular neck.” Fractures in the neck may cause patients to experience sudden pain, instability and require revision surgeries to remove and replace the neck and stem components, the agency said.
Revision surgeries and acute fractures can have serious adverse health risks that can lead to neurovascular damage, hematoma, hemorrhage or death, the FDA said.
A total 10,825 units from all lots of the device are affected by the recall, manufactured between June 15, 2009 and July 22, 2015 and distributed between June 15, 2009 and July 31, 2015.
MicroPort began notifying patients and customers with the products August 7. The company instructed distributors and hospital staff to locate the affected units, discontinue distribution and return the products to MicroPort.
The company advised patients with the implants to monitor their health and seek immediate help if they experience any sudden onset of severe pain, difficulty or inability to walk, any trauma to the hip or leg or a tingling sensation or loss of feeling in their leg.
A year earlier, Wright Medical said they had received a subpoena from the U.S. Attorney’s Office for the Western District of Tennessee requesting records relating to the its ProFemur metal hip implants.
The office requested documentation covering the period from Jan. 1, 2000, to Aug. 2, 2012 over issues with the metal stems.