The FDA has released a note regarding MicroPort Orthopedics Inc. recall on their PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254, which is a modular neck component used with prosthetic parts including a femoral head and femoral stem in total hip replacement surgeries.
Post surgery, this modular neck model has been known to fracture in patients. Immediate symptoms include sudden pain and instability coupled with a difficulty in walking or completing simple tasks.
A revision surgery is required in order to remove and replace the fractured neck, and any other components that have been damaged. And it should be noted that along with this defect and revision surgery, serious health events could occur, including neurovascular damage, hematoma (a solid swelling of clotted blood within the tissues), hemorrhage (an escape of blood from a ruptured blood vessel, especially when profuse) and even death.
Health care professionals and doctors have all been alerted to this recall.
If you believe to have been a recipient of this defective modular neck, you should contact your doctor immediately.
Also, if you have experienced any adverse affects of this unit, or any other bad drug or faulty medical device, you should make it a point to alert the FDA’s MedWatch to help insure that the products medical manufactures produce are properly scrutinized for patient safety.