JANUARY 13, 2017 BY BRAD PERRIELLO
Johnson & Johnson (NYSE:JNJ) is recalling its DePuy Synthes radial head prosthesis because of the risk of loosening in the component that anchors the implant in the arm’s radius bone.
The entire prosthesis is designed for primary and revision replacement of the radial head, but only the radial stem surgeons insert into the radius is involved in the loosening issue, according to a letter the J&J unit sent to physicians Dec. 30, 2016.
“Based on the currently available data, we believe the cause to be multifactorial (including possible product characteristics, operative and patient factors), but we have not been able to fully characterize these factors. Consequently, we have not been able at this time to issue further instructions to surgeons that might lead to a reduction in issue rate and have decided to remove the DePuy Synthes Radial Head Prosthesis Stem from the global market,” the company wrote.
If the radial stem loosens, the risks include osteolysis, poor joint mechanics, pain, post-operative fracture and soft tissue damage, J&J said.
Patients already implanted with the device should be followed as normal and the device will still be available on request for revision surgeries “in which only the head would be replaced using the evaluation or loaner set programs only,” according to the letter.
FILED UNDER: ORTHOPEDICS, RECALLS, REGULATORY/COMPLIANCE
TAGGED WITH: DEPUY SYNTHES, JOHNSON & JOHNSON
DePuy Elbow Implant Lawsuit Evaluations Offered By Bernstein Liebhard LLP Following Class II Recall for Synthes Radial Head Prosthesis System
NEW YORK, April 11, 2017 /PRNewswire/ -- The nationwide law firm of Bernstein Liebhard LLP is now investigating potential product liability lawsuits involving the recall of more than 50,000 DePuy Synthes Radial Head Prosthesis Systems. The DePuy elbow implant components were removed from the global market in December out of concern that the radial stem could loosen at the stem-bone interface following implantation. The U.S. Food & Drug Administration (FDA) has declared this action a Class II medical device recall, which indicates that recipients of the DePuy Synthes Radial Head Prosthesis System may be at risk for temporary or medically reversible health consequences.
"Individuals who allegedly suffered complications related to this DePuy elbow implant recall could be entitled to compensation for medical bills, lost wages and other injury-related damages. However, it is important that those affected act quickly to ensure that their legal rights are protected," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is now offering free, no-obligation case reviews to individuals who may be eligible to file a DePuy elbow implant lawsuit.
DePuy Synthes Radial Head Prosthesis System
The DePuy Synthes Radial Head Prosthesis System was cleared via the FDA's 510(K) protocols in June 2011, which do not require human clinical trials when a device is shown to be "substantially equivalent" to a product that was previously approved by the agency. The DePuy elbow implant system is indicated for primary and revision replacement of the radial head.
DePuy Synthes announced that it was removing the Radial Head Prosthesis System from the worldwide market in December 2016, due to the potential for the radial stem to loosen at the stem-bone interface. Complications associated with radial-stem loosening include:
- Osteolysis
- Poor joint mechanics
- Pain
- Post-operative fracture
- Soft tissue damage
DePuy Synthes noted that multifactorial issues (including possible product characteristics, as well as operative and patient factors) could be to blame for radial-stem loosening. Because it was unable to determine the exact cause, the company could not issue further instructions to surgeons that might mitigate the problem.
The FDA granted the DePuy elbow implant recall a Class II designation in February 2017.
Patients who experienced complications related to radial-stem loosening of the DePuy Synthes Radial Head Prosthesis System may be entitled to compensation. To learn more about filing a DePuy elbow implant lawsuit, please visit Bernstein Liebhard LLP's website, or call 800-511-5092 to arrange for a free, no obligation case review.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3.5 billion on behalf of our clients. Bernstein Liebhard LLP is honored to once again be named to The National Law Journal's "Plaintiffs' Hot List," recognizing the top plaintiffs firms in the country. This year's nomination marks the thirteenth year the firm has been named to this prestigious annual list.
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3.5 billion on behalf of our clients. Bernstein Liebhard LLP is honored to once again be named to The National Law Journal's "Plaintiffs' Hot List," recognizing the top plaintiffs firms in the country. This year's nomination marks the thirteenth year the firm has been named to this prestigious annual list.
Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
800-511-5092
ATTORNEY ADVERTISING. © 2017 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Contact Information:
Sandy A. Liebhard, Esq.
Bernstein Liebhard LLP
info (at)consumerinjurylawyers(dot)com
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