FDA Issues Warning: Increased Risk of Thigh Bone Fractures With Zimmer Biomet CPT Hip System Femoral Stem

Artificial hips offer a new lease on life to many thousands of people each year. They provide recipients the opportunity for independent living and mobility they might not otherwise have. Unfortunately, they also come with risks, one of the most prominent being metallosis. But there’s also another potential risk where the femur (thigh bone) could break.

The femur is the largest and strongest bone in the body. Yet the process of implanting an artificial hip, along with the older age of most patients who receive artificial hips, means there’s a greater risk of a thigh bone fracture. If this happens, artificial hip revision surgery may be needed.

The U.S. Food and Drug Administration (FDA) recently issued a safety communication alerting patients with the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper of an increased risk of thigh bone fracture. Let’s take a look at this safety communication and what you should do if you received this implant.

Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper Fracture Risks

Just to make things clear, practically all medical treatments come with some risks. So the question isn’t about whether there’s a risk, but the level of risk and whether a patient is properly told those risks so they can make an informed decision.

That being said, the primary issue here isn’t that there’s a bone fracture risk if you receive the Zimmer Biomet CPT Hip System Femoral Stem 12/14 Neck Taper (Zimmer CPT Hip System). This is because most artificial hips have some risk of the thigh bone breaking after the surgery. The primary issue is instead whether you’re properly told about the risk of fracturing your femur should you receive this particular artificial hip, and whether this particular artificial hip carries a heightened risk of bone fracture.

The FDA cites a UK study that found that the Zimmer CPT Hip System had a risk of thigh bone fracture that was roughly 1.4%. This doesn’t sound like much, but it’s almost double the fracture rates of comparable artificial hip products. These other artificial hips had a fracture risk that ranged between 0.6% and 1.0%.

Based on this information, Zimmer Biomet initiated a voluntary recall of the Zimmer CPT Hip System to provide updated instructions that would include the risk of femur fracture. Zimmer Biomet also explained that they would stop selling this particular artificial hip by December 2024.

How Do I Know if I Received an Affected Artificial Hip from Zimmer Biomet?

The best way is to ask your doctor or other health care professional. If you’re curious about the specific models, you can find an affected product list in the FDA’s safety communication or on Zimmer Biomet’s website (it’ll be on Attachment 2).

What Should I Do If I Received an Affected Artificial Hip?

If you don’t have any unexpected problems walking, or pain around your hip, then you’re probably fine as long as you maintain the follow-up schedule with your doctor. The FDA doesn’t recommend surgery to remove the artificial hip if you aren’t experiencing any problems with it. However, it’s still a good idea to talk to your doctor to know if you have an affected device and confirm that there’s nothing additional you need to do or avoid doing.

If you’re having problems with your Zimmer CPT Hip System, then you should contact your doctor as soon as you can. They can review your situation and recommend your next course of action. You may also want to report your issue to MedWatch, which is administered by the FDA.

If you received a hip replacement surgery that used the Zimmer CPT Hip System and aren’t having any issues with it, that’s good news. But if you’re in pain, have trouble walking, or suffered a broken femur where the artificial hip was installed, legal action might be a possibility. If you want to learn more, call me at 919.334.6277 or contact me online. In the meantime, you can talk to your doctor if you have any questions or concerns. Good luck.