Lawsuits Filed over Smith & Nephew Tandem Bipolar Hip SystemsFeb 28, 2017
Tandem Bipolar Hip System Can Detach Following Surgery, Lawsuits Mount
Lawsuits are being filed against Smith & Nephew on behalf of individuals implanted with the Tandem Bipolar Hip System. Litigation has been mounting since the device was recalled in August 2016. The hip system can cause adverse events if the hip device detaches after surgery. The hip implant component has been recalled in both the United States and Australia.
The product liability lawyers at Parker Waichman LLP have decades of experience representing clients in lawsuits over allegedly defective or dangerous products. The firm continues to offer free legal consultations to individuals with questions about filing a Smith & Nephew hip implant lawsuit.
According to a recall alert posted on the U.S. Food and Drug Administration (FDA) website, the Tandem Bipolar Hip System was recalled because "some Bipolar shells were manufactured with an out-of-specification retainer groove." The agency designated the recall as Class 2, indicating a situation where a recalled device could lead to temporary or medically reversible injuries, or where the risk of serious injury is remote.
Regulators in Australia also issued a similar warning. The country's regulatory agency issued a "hazard alert" warning that the faulty retainer groove "could lead to three potential failures, including the device not assembling properly and the head being too tight and not moving freely. Both of these failures would be identified during preparation before the implantation surgery,"
"The third potential failure is the device may appear to be assembled properly during the implantation surgery, but parts become detached at a later time."
In addition to the Tandem Bipolar Hip System recall, Smith & Nephew has also recalled other hip replacement products. The company recalled its Modular Redapt Hip System, the Modular SMF Hip System, and Modular Necks shortly afterwards, "due to a higher than anticipated complaint and adverse event trend." The recall affects a total of 32,000 hip replacement products.
Smith & Nephew notified physicians of the issue through a "Dear Doctor" letter. "Based on an analysis of available data sets, Smith & Nephew considers that patients implanted with the modular neck hip prostheses may be at greater risk of revision surgery than with comparable monolithic products," the company said. "For this reason, on a precautionary basis Smith & Nephew is issuing a voluntary field safety corrective action for the modular neck hip prostheses,"
These hip replacement products were approved via 510(k), the FDA's fast-track process for approving medical devices without clinical testing. This contrasts with the agency's premarket approval (PMA) process, which is stricter. In PMA, device makers must submit clinical data proving that their devices are safe and effective prior to obtaining approval. 510(k), however, does not require clinical data. Manufacturers are only required to prove "substantial equivalence", meaning that products are at least as safe as a previously approved device.
Many medical device injury lawsuits are filed over products approved through 510(k). Examples include metal-on-metal hip implant products, transvaginal mesh, hernia mesh, and many other devices. Plaintiffs, safety advocates and experts have argued that 510(k) is not adequate for certain medical devices, and the prevalence of its use has allegedly caused patients to suffer unnecessary harm.
Smith & Nephew Sued over BHR, R3 Metal-on-Metal Hip Implants
Smith & Nephew has also been involved in litigation over its Birmingham Hip Replacement (BHR) system and R3 Acetabular System. Plaintiffs suing over these metal-on-metal hip devices have asked for lawsuits to be consolidated into a federal multidistrict litigation (MDL), a type of mass tort that transfers lawsuits to one court to make legal proceedings more efficient.
The company recalled the R3 in 2012; the BHR was withdrawn in 2015. Lawsuits allege that the devices cause adverse events such as pain, inflammation, bone damage and metallosis (metal poisoning). Plaintiffs allege that these injuries stem from the defective metal-on-metal design of the hip implants.
With metal-on-metal hip implants, the surfaces of the implant are all made of metal. These devices can release metallic debris when the surfaces of the implant rub together, causing complications that lead to early device failure. Several different device makers, including DePuy Orthopedics, Wright Medical, Zimmer, Biomet and Stryker, have faced metal-on-metal hip implant litigation.
Filing a Hip Replacement Lawsuit
Parker Waichman has years of experience representing clients in medical device injury lawsuits. If you or someone you know is interested in filing a hip replacement lawsuit, contact one of our experienced product liability lawyers today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).