<![CDATA[Zimmer Biomet - Hodges Law, PLLC]]> https://www.clayhodgeslaw.com/blog/tags/zimmer-biomet/ Thu, 02 Apr 2026 17:43:51 GMT en-us <![CDATA[FDA Issues Warning: Increased Risk of Thigh Bone Fractures With Zimmer Biomet CPT Hip System Femoral Stem]]> https://www.clayhodgeslaw.com/blog/fda-issues-warning-increased-risk-of-thigh-bone-fractures-with-zimmer-biomet-cpt-hip-system-femoral-stem/ https://www.clayhodgeslaw.com/blog/fda-issues-warning-increased-risk-of-thigh-bone-fractures-with-zimmer-biomet-cpt-hip-system-femoral-stem/ Tue, 01 Oct 2024 12:35:46 GMT Zimmer Biomet initiated a voluntary recall of the Zimmer CPT Hip System to provide updated instructions on the risk of femur fracture. Zimmer Biomet also explained that they would stop selling this particular artificial hip by December 2024.

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Zimmer Biomet CPT Hip System

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.

Zimmer Biomet CPT Hip System and femur fractures

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) 830-5602 or contact me online. In the meantime, you can talk to your doctor if you have any questions or concerns. Good luck.

]]> <![CDATA[Zimmer Biomet Reverse Shoulder Product Recall: What You Should Know]]> https://www.clayhodgeslaw.com/blog/zimmer-biomet-reverse-shoulder-product-recall-what-you-should-know/ https://www.clayhodgeslaw.com/blog/zimmer-biomet-reverse-shoulder-product-recall-what-you-should-know/ Tue, 21 Feb 2017 15:20:00 GMT Shoulder replacement surgeries are common and provide relief to thousands. But some conventional shoulder replacement surgeries don’t work, requiring a different type of shoulder replacement surgery. In a typical shoulder replacement, artificial components replace natural ones, such that an artificial cup is placed into the shoulder while an artificial ball is placed at the top…

]]> Shoulder replacement surgeries are common and provide relief to thousands. But some conventional shoulder replacement surgeries don’t work, requiring a different type of shoulder replacement surgery.

In a typical shoulder replacement, artificial components replace natural ones, such that an artificial cup is placed into the shoulder while an artificial ball is placed at the top of the humerus, or arm bone. For individuals with rotator cuff tears and arthropathy, which is a complex type of shoulder arthritis, this type of shoulder replacement surgery doesn’t work.

Instead, patients must obtain a reverse shoulder replacement, which places the ball in the shoulder and the cup at the top of the humerus. One such reverse shoulder replacement medical device is Zimmer Biomet’s Comprehensive Reverse Shoulder System. However, this product has recently been recalled by Zimmer Biomet.

The Reverse Shoulder Recall

Zimmer Biomet Reverse Shoulder Recall

On December 15, 2016, Zimmer Biomet recalled its Comprehensive Reverse Shoulder System, noting that it was fracturing far more often than expected and could lead to serious problems, such as infection, inability to use the shoulder and even death. Fracturing is an unusual problem, since most shoulder replacement complications do not involve fracturing, but instead deal with excessive wear, dislocating and loosening of joint components.

Due to the severity of the problem with the Comprehensive Reverse Shoulder System, the U.S. Food Drug and Administration (FDA) classified this recall as a Class I recall, which is the most serious type of recall available.

Several thousand patients are possibly affected by this recall, with a total of 3,662 total devices in question. Doctors and healthcare providers who have used this shoulder implant should have already been notified about the recall. Some affected patients may have also received notice from their doctor about the recall. However, in case no such notice has been provided, the following is additional information about the product being recalled:

  • Trade Name: Biomet Comprehensive Reverse Shoulder Humeral
  • Distribution Date: Between October 2008 and September 2015
  • Manufacture Date: Between August 25, 2008 and September 27, 2011
  • Product Codes: KWS and PAO
  • Lot Number: 115340

Currently, Zimmer Biomet is working on identifying and recovering the affected medical devices so they can no longer be used in patients. So far, Zimmer Biomet hasn’t indicated any particular signs to look for in affected patients and believes maintaining the current post-surgery follow-up protocols are adequate. However, this doesn’t mean there’s nothing you can do.

What Happens Next?

If you have had reverse shoulder replacement surgery and believe you may have an affected product, see your orthopedic surgeon as soon as you can. If you can confirm you are a recipient of Zimmer Biomet’s Comprehensive Reverse Shoulder System, you may want to discuss your legal options with an experienced products liability attorney, and discuss your medical options with your orthopedic surgeon.

Attribution: Photo of Reverse Shoulder product courtesy of FDA Website, which permits republication. FDA post on the Reverse Shoulder product recall can be accessed here.

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