Zimmer Biomet Lawsuit Filed Over RibFix Blu Implant Fracture

Lawsuit indicates an electron microscope detected stress fractures in unbroken portions of three Zimmer Biomet RibFix implants, suggesting the material was fatiguing over time.

An Alabama man has filed a product liability lawsuit against Zimmer Biomet, indicating that three of the manufacturer’s RibFix Blu rib implants suffered “terminal fractures,” which were caused by normal wear and tear from one year of breathing after the rib plates were implanted.

The RibFix Blu Thoracic Fixation System is used to stabilize ribs that have suffered traumatic fractures. Also known as “rib plates,” the implant is the only intrathoracic fixation system on the market, consisting of a bridge plate, locking posts and locking caps. The system is designed to allow minimal invasive surgical procedures, with the bridge plates pre-contoured so as to not require the surgeon to have to bend them to the shape of the patient’s ribs during the implantation procedure.

However, in a complaint (PDF) filed against Zimmer Biomet Holdings, Inc. in the U.S. District Court for the Northern District of Alabama on September 6, Michael Wayne Hopper indicates that the RibFix Blu System is unreasonably dangerous and defective, with problems arising from the normal and anticipated use of the product.

The RibFix Blu lawsuit alleges that the design of the rib plates causes stress fatigue that builds up over time, potentially causing rib plate fractures and failure after the device is implanted in the body.

Hopper indicates that he received three RibFix implants in September 2021, for his third, fourth and fifth ribs on his right side. However, by November 2022, he was experiencing such increasing pain in his right chest that doctors performed a CT scan, which showed fractures in all three ribs.

An electron microscope examination revealed that the implants showed significant post-fracture damage, and the material appeared to have been “peened-out”, meaning it was bent, flattened or smeared, according to the complaint. Even the undamaged surfaces of the RibFix implants showed signs of fatigue, indicating that the implants suffered material damage that led to terminal fractures, according to the analysis.

“More probably than not, the cause of the fatigue and fracture of the three RibFix Blu Thoracic Fixation System devices…was the expansion and contraction of Plaintiff’s rib cage during ordinary breathing over the course of more than one year following implantation,” Hopper states in his lawsuit. “Defendant, as the original seller of the thoracic plating system is liable to Plaintiff for the damages proximately caused by a characteristic of the product that rendered it unreasonably dangerous, as such danger arose from a reasonable anticipated use of the product by the Plaintiff.”

Hopper’s lawsuit presents claims of violations of Alabama manufacturer’s liability laws, negligence and breach of warranty.

Zimmer Biomet CPT Hip System Warning

The case was filed just days before the U.S. Food and Drug Administration (FDA) issued a safety communication about problems with another product sold by the same manufacturer, warning doctors to avoid implanting patients with the Zimmer Biomet CPT Hip System Femoral Stem, if possible.

The agency indicated that recent research revealed that individuals with the Zimmer CPT hip systems faced a higher risk of thigh bone fractures, when compared to hip replacement devices of a similar design.

In July, Zimmer issued updated instructions on the hip implants, indicating they would phase out the sale of the devices by December 2024. However, the manufacturer did not remove the hip devices from the market entirely.

While the FDA is not recommending those with functioning Zimmer CPT hip systems have them surgically removed, it is urging health care professionals to consider using alternative devices, if they are available.

No warnings have been issued about problems with Zimmer Biomet RibFix Blu implants fracturing after they are implanted.