On Tuesday, the FDA published a warning related to Zimmer Biomet’s early July recall of its CPT Hip System Femoral Stem 12/14 Neck Taper (CPT Hip System). The FDA cautions patients and healthcare professionals that the updated instructions provided by Zimmer Biomet are likely insufficient to address the problems noted in the recall.
Zimmer Biomet announced the recall on July 2, 2024, to address concerns about an increased risk of femoral fracture following hip surgeries using the CPT Hip System. The recall provided amended instructions for healthcare providers when using the CPT Hip System and disclosed plans to discontinue the device by December of 2024.
While medical professionals continue to utilize the CPT Hip System with the updated instructions from Zimmer Biomet, the FDA has reviewed new evidence from the Medicines and Healthcare products Regulatory Agency (MHRA) suggesting that the CPT Hip System still increases the risk of femoral fracture for patients after surgery. The FDA urges health care providers and patients to understand that while the CPT Hip System may remain available until December, the device may be unsafe because Zimmer Biomet’s updated instructions do not reduce the increased risk of fracture.
As part of its warning, the FDA offers the following suggested guidelines for patients and healthcare providers:
For patients —
- If you are planning on undergoing hip replacement surgery, have a thorough conversation regarding all of the available hip replacement devices and the risks and advantages of each.
- Consider the increased risk of thigh bone fracture with Zimmer Biomet’s CPT Hip System and discuss this risk with your doctor.
- If you have already had hip replacement surgery using the CPT Hip System, report any and all problems or complications to your doctor and the FDA. Symptoms of particular concern include pain and “difficulty when walking.” If you are symptom-free, maintain your follow-up schedule; there is no need for medical intervention if the device is not causing you problems.
For healthcare providers —
- Be aware of the concerns referenced above and encourage patients to review the information.
- Consider the benefits and risks when recommending specific hip replacement devices to patients and only suggest the CPT Hip System when other (and safer) devices aren’t available.
- When use of the CPT Hip System is unavoidable, educate patients about the increased risk of postoperative femoral fracture.
- Understand the risks and carefully monitor patients who have already undergone hip replacement surgery with the CPT Hip System.
- Report all problems with the CPT Hip System to the FDA.
Patients and health care providers can report any new adverse health events related to Zimmer Biomet’s CPT Hip System through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an adverse health outcome, such as femoral fracture, after undergoing hip replacement surgery with Zimmer Biomet’s CPT Hip System, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to health care facilities in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.