|Titan Spine's Endoskeleton TL for spinal fusion, now under warranty.--Courtesy of Titan Spine|
Titan Spine yesterday announced that it's becoming the first spine implant manufacturer to offer a warranty on its products. The 5-year warranty of its Endoskeleton line of spinal interbody fusion devices is the orthopedics industry's second product guarantee, joining Biomet's lifetime warranty of its Oxford Partial Knee.
"Over the last few months, we've received positive feedback regarding our warranty from the field and we are proud to offer it as a testament to the knowledge that our products are engineered for optimal success in patients. Ultimately, the warranty demonstrates the significant confidence we have in our products and the science validating our surface technology," CEO Dr. Peter Ullrich said in a statement.
The warranty offers a one-time free replacement of the covered devices if revision surgery is required within 5 years "for any reason other than physician error or the failure of the patient to follow post-operative instructions (including but not limited to post-operative instructions relating to limitations on physical activity)," according to an email from a Titan spokeswoman.
The key feature of the Endoskeleton products is their roughened titanium surface technology, which promotes bone growth and fusion, according to the company. There are 6 devices in the line, encompassing all of Titan's products. The implants are geared toward degenerative disc disease, according to the company website. In July, Titan received 510(k) clearance for the latest addition, the Endoskeleton TL System implant for spinal fusion.
Patient advocates such as the policy arm of the Consumers Union have been mounting an aggressive campaign to convince industry players to offer warranties on their implants. In August the Consumers Union's Safe Patient Project sent a 12,000-signature petition to the Federal Trade Commission calling for hip and knee implant warranties.
The group worries that Biomet's warranty of its Oxford Partial Knee could be endangered by the company's looming merger with Zimmer ($ZMH). It was first offered in 2012. That warranty is generous, covering the product for life for any reason. But a Consumers Union spokeswoman said in an email that the organization thinks Biomet should also cover the medical expenses for the replacment surgery.
In spite of his company's warranty, Biomet CEO Jeffrey R. Binder expressed concern about warranties in 2010. In a rare instance of industry comment on the topic, he wrote on his personal corporate blog: "It is well-established, almost to the point of cliché, that the reasons for orthopedic implant failures are multi-factorial. In a very small minority of cases, the cause of failure is obvious and can be neatly assigned to one party."
- read the release
- here's the Consumers Union initiative