Zimmer to Phase Out CPT Device, but FDA Wary of Existing Inventory

Zimmer Biomet to phase out the LDR bone growth stimulator implant after 8 reports of serious infections

On November 23, 2023, Zimmer Biomet announced its plan to discontinue sales of its LDR bone growth stimulator, marketed as the Comprehensive Pulse Technology (CPT) device, after receiving eight reports of serious infections, including two that led to death.

The LDR is a surgically implanted device that uses electrical pulses to stimulate bone growth and is commonly used in spinal fusion surgeries.

FDA Warns Against Using Existing Inventory

The FDA is advising hospitals and clinics not to use any remaining inventory of Zimmer Biomet’s LDR bone growth stimulators. The agency is also asking healthcare providers to report any adverse events related to the device.

In a statement, the FDA said, “The FDA is aware of eight serious adverse events, including two deaths, associated with the use of Zimmer Biomet’s LDR bone growth stimulator. We are currently investigating these events and will provide additional updates as they become available.”

Possible Infection Risk

The FDA’s investigation into the LDR bone growth stimulator is ongoing, but the agency believes that the infections may be related to a design flaw in the device.

The LDR is implanted in the epidural space, which is a narrow space between the spinal cord and the bones of the spine.

The FDA believes that the LDR’s design may allow bacteria to enter the epidural space and cause an infection.

Zimmer Biomet to Offer Refunds and Replacements

Zimmer Biomet has stated that it will offer refunds or replacements to customers who have purchased the LDR bone growth stimulator.

The company has also set up a website where customers can submit claims for refunds or replacements.

What Patients Should Do

If you have had an LDR bone growth stimulator implanted, you should talk to your doctor about the risks and benefits of the device.

You should also monitor yourself for any signs of infection, such as fever, chills, or pain at the site of the implant.

If you experience any of these symptoms, you should see your doctor immediately.

Conclusion

The FDA’s announcement about the LDR bone growth stimulator is a reminder of the importance of patient safety.

The agency is taking steps to ensure that patients are not exposed to unnecessary risks from medical devices.

Patients should always talk to their doctor about the risks and benefits of any medical device before undergoing a procedure.