FDA RECALLS PROFEMUR HIP STEMS
URGENT NEWS: The FDA has issued a Class 1 recall of certain Wright Medical Profemur modular neck stems. The recall is due to an unexpectedly high number patients across the U.S. have reported a snapping, or fracture, of their Profemur hip system at the stem.
The FDA describes a class 1 recall as “the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
Maglio Christopher & Toale, P.A. is a leading medical product liability law firm with a nationwide practice representing people hurt by defective hip implants.
How one of our clients, a former police officer who was shot in the line of duty, described the feeling when his Wright Medical Profemur hip stem snapped.
Wright Medical Profemur Modular Stem Fractures
The photo on the left is a graphic example of a Profemur stem fracture. These fractures happen to people suddenly and without warning. Additionally, the FDA says there’s no way to predict who will suffer a fracture based on patient history, exam, X-ray, MRI or CT scans.
Our hip recall team at Maglio Christopher & Toale, P.A. have represented many people with fractured hip stems in lawsuits against the companies that make these defective parts. Click here to read just one of the complaints filed by Maglio Christopher & Toale, P.A. on behalf of our stem fracture clients.
Why are Hip Replacement Stem Fractures so Severe?
The fractured stem (also called the “neck”) is usually tightly fixed into place within the femur because bone grows around the stem. Furthermore, when it breaks, bends or fractures, the surgeon may have to peel or chisel out the entire stem from your bone.
One surgeon described the procedure to our attorneys as being similar to peeling a banana. But in this case, the actual bone is peeled away from the metal stem inside. Once the broken stem is out, the surgeon wraps the peeled flaps of the femur around a new metal stem and then wires the whole thing together.
Even if the surgeon doesn’t need to use such brutal force to remove the stem, any unnecessary re-surgery of a hip replacement involves significant pain, immobility, and very long recovery.
Symptoms of Hip Stem Fracture
- A complete fracture of a hip replacement stem or neck is instantly apparent. You’ll feel severe pain as soon as you put pressure on the broken implant.
- You may notice that the implant feels loose inside your hip area.
- Patients may have trouble standing or walking, especially if the fracture is severe.
- You will likely feel intense pain and discomfort immediately after the stem fractures.
What is Different about the Profemur Hip System?
The Wright Medical Profemur stem includes an additional component from a standard hip replacement, a modular neck. This neck connects the head or ball with the stem that is implanted into the patient’s femur.
There are 4 types of Wright Medical Profemur stems that utilize these modular necks that have experienced fractures:
PROFEMUR Gladiator, PROFEMUR Renaissance, PROFEMUR TL, and PROFEMUR Z
Contact Maglio Christopher & Toale, P. A.
If you have had a Profemur hip stem fracture, speak with an attorney experienced in this problem as soon as possible. You can contact the lawyers at Maglio Christopher & Toale, P.A. at (888) 952-5242 or fill out the online form below. One of our attorneys will get in touch with you shortly.