Zimmer Biomet CPT Hip System Linked to Increased Risk of Thigh Bone Fractures, FDA Warns

FDA urges doctors to avoid implanting new patients with the Zimmer Biomet CPT hip replacement system unless no other alternatives are available.

Patients implanted with the Zimmer Biomet CPT Hip System Femoral Stem face an increased risk of experiencing serious femur fractures after surgery, according to a new warning issued to patients, caregivers, health care providers and facilities nationwide.

In a safety communication issued on September 17, the U.S. Food and Drug Administration indicated that alternative joint replacement implants should be used whenever possible, since the Zimmer Biomet CPT hip system may double the risk of thigh bone fractures, compared to outcomes associated with similar hip systems.

The warning comes after a Zimmer Biomet hip recall was issued by the manufacturer in July 2024, indicating that it will also phase out the sale of the device by December 2024. However, the recall only updated instructions for the devices, and did not remove the Biomet hip system from the market.

“[T]he FDA has concerns about the CPT Hip System continuing to be implanted in new patients, given recent research that found a higher risk of thigh bone fracture with the device compared to hip replacement devices of a similar design, and the likely need for surgical intervention if the fracture occurs,” the FDA safety communication states. “The FDA is working with the manufacturer to address these concerns.”

According to the agency, the warning is based on information released by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) earlier this month. The analysis (PDF) found that patients with the Zimmer Biomet hip system’s femoral stems face a 1.4% risk of femur fractures, much higher than the average for these types of devices, which range from 0.6% to 1%, depending on the model.

The FDA is now recommending patients discuss the risks with their doctors whenever they are considering a hip replacement device, to ensure they are aware of the increased risk of thigh bone fractures with the Zimmer Biomet implants. They should consult with their healthcare professionals if they experience unexpected pain and difficulty walking after receiving a CPT hip system, and should continue their existing follow-up schedule even if they do not have any symptoms.

The agency is not recommending removal of the Zimmer Biomet CPT Hip System if patients have not experienced problems. However, doctors are being urged to consider using alternative systems if possible, with the FDA recommending the Zimmer Biomet systems only be used when the benefits outweigh the risks, “and when appropriate alternative devices are not available.”

The agency also recommended doctors warn patients who have to get the system of the increased risks, and be aware themselves of the potential for femur fractures in patients already implanted with the hip system.

The FDA is urging health care professionals and patients to report any problems with the device to FDA’s MedWatch adverse event reporting system.