MicroPort PROFEMUR Recall
POST DATE Oct 23, 2015
When the joints in the hip are damaged to the point of causing intense pain—pain that persists even with pain medication or walking aids, makes sleeping difficult and turns each set of stairs into an obstacle—hip replacement surgery can become necessary. These symptoms typically coincide with a diagnosis of Osteoarthritis, Rheumatoid arthritis, or Osteonecrosis. While specific symptoms and causes of each diagnosis differ, hip replacement surgery aims to remove the damaged portion of the hip joint and replace it with a prosthesis, usually made of metal and very hard plastic. These parts specifically include a femoral head, femoral stem, and modular neck.
For anyone who has recently undergone hip replacement surgery: there has been a Class I Recall from MicroPort Orthopedics of part number PHAC 1254, PROFEMUR Neck Varus/Valgus CoCr due to an unexpected report of fracture rates. Should the modular neck fracture, the patient could suffer from sudden pain, instability, and difficulty walking or performing common tasks. According to the FDA, an “acute fracture will require revision surgery to remove and replace the neck and stem components.” This is a very grave concern; acute fracture and emergency revision surgery is “a serious adverse health consequence,” one which could lead to neurovascular damage, hematoma, hemorrhage, and even death.
This is a voluntary device product recall, issued August 7, 2015. At that time, MicroPort Orthopedics informed distributors and hospital staff about the defects; the aforementioned, along with risk managers and surgeons, were instructed to cease use of this product and return the defected material to MicroPort Orthopedics.
PROFEMUR products were previously manufactured under the brand Wright OrthoRecon. Wright was purchased by MicroPort in January of 2014 so the PROFEMUR equipment used in hip replacement surgeries conducted prior to this time used the Wright OrthoRecon brand name instead of MicroPort.
If you or someone you know has recently undergone hip replacement surgery and you have questions regarding this recall, you can contact MicroPort Orthopedics at their Customer Experience Department at 1-866-872-0211, Monday through Friday, between the hours of 7:30 a.m. and 7:30 p.m. Central Standard Time.
To explore legal options regarding adverse side-effects of the MicroPort Orthopedics recall, please call the offices of Brad Bradshaw, MD JD LC at 1-888-775-0000.