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 recall.
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.
ProFemur products were formerly manufactured by a division of Wright Medical. In January, MicroPort bought Wright Medical’s OrtrhoRecon hip and knee implant business, including its ProFemur properties.
If you or a loved one is suffering any sudden onset of severe pain, difficulty or inability to walk, or a tingling sensation or loss of feeling in the leg after a hip replacement surgery, call Phelan |Petty, PLC.