Smith and Nephew Recalls Modular Hip System Products
Smith and Nephew is recalling another 32,000 hip implant products due to higher than expected complaints and adverse events. The Class 2 recall affects the Modular Redapt Hip System, the Modular SMF Hip System, and Modular Necks. This recall follows the Tandem Bipolar Hip System recall. For several years, the company has faced litigation involving its metal-on-metal hip implants.
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 the three recall alerts posted on the U.S. Food and Drug Administration (FDA) website, the recall affects 6,266 units of the Modular Redapt Hip Systems, 11,999 units of the Modular SMF Hip System, and 13,671 units of Modular Necks. Smith and Nephew is recalling 32,000 hip implant products in total “due to a higher than anticipated complaint and adverse event trend.”
In a “Dear Doctor” letter, Smith and Nephew wrote “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,”
“For this reason, on a precautionary basis Smith & Nephew is issuing a voluntary field safety corrective action for the modular neck hip prostheses,”
The recalls have been designated as Class 2 by the FDA. Class 2 recalls indicate a situation where exposure to the recalled device can lead to temporary or medically reversible health problems, or where the risk of serious injury is remote.
This recall follows another Smith and Nephew hip implant recall of its Tandem Bipolar Hip System. The company recalled 5,806 units in August 2016 because “Some Bipolar shells were manufactured with an out of specification retainer groove.”
Regulators in Australia also issued a “hazard alert” for Smith and Nephew Tandem Bipolar hip implants, stating that the issue “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.”
Lawsuits have previously been filed against Smith and Nephew over injuries allegedly caused by its metal-on-metal hip implants.
Smith and Nephew Metal-on-Metal Hip Implant Lawsuits
Product liability lawsuits have been filed against Smith and Nephew involving the company’s metal-on-metal Birmingham Hip Replacement (BHR) system and R3 Acetabular System. The BHR was withdrawn from the market in 2015 and the R3 was recalled in 2012.
According to court records, plaintiffs in the Smith and Nephew hip replacement litigation are seeking a federal multidistrict litigation (MDL) to consolidate R3 and BHR lawsuits. An MDL is a type of mass tort that transfers similar lawsuits to one court. The U.S. Judicial Panel on Multidistrict Litigation (JPML) establishes MDLs to speed up litigation and make the overall process more efficient. For example, the discovery phase and expert testimonies can apply to all cases in an MDL, rather than being repeated for each lawsuit. Plaintiffs submitted a petition for consolidation on Feb. 1, 2017, court documents show.
Hip replacements can be made with various materials, including metal, plastic, and ceramic. As the name implies, a metal-on-metal hip implant is a hip replacement device where the surfaces are all made of metal. When these products were first introduced, they were marketed as being more durable and better suited for younger, more active patients. However, in recent years, experts have discovered that metal-on-metal hip implants can shed metal debris into the body when the surfaces of the implant rub together.
Adverse events associated with metal-on-metal hip implants include metallosis (metal poisoning), bone damage, tissue damage, pain, inflammation, pseudotumors, immobility and other complications. In some patients, complications became so severe that the hip implant “failed”, prompting the need for revision surgery to remove and replace the device.
Hip replacements are expected to last at least 10 or 15 years, but some metal-on-metal hip implants have been recalled due to a high rate of early failure. The devices came under fire when DePuy Orthopaedics issued a worldwide recall for its ASR hip implants in 2010.
Safety advocates, experts, and plaintiffs point out that metal-on-metal hip implants were approved and subsequently implanted in thousands of patients without substantial clinical testing. This is because device makers obtained clearance for metal-on-metal hip implants through 510(k), the FDA’s fast-track route for approving medical devices. Rather than providing clinical data showing that the devices are safe and effective (as is required under the stricter premarket approval process), manufacturers only need to prove “substantial equivalence”. This means that the new device is at least as safe as a previous device, even if that product had safety issues of its own.
510(k) has come under criticism, following safety concerns with metal-on-metal hip implants and other controversial devices approved through this route. Metal-on-metal hip implants are classified as “high-risk”; the designation should have meant that they were barred from 510(k) approval. However, medical device companies were able to approve metal hip replacements through this expedited process due to a regulatory loophole.
In the past, the JPML has created MDLs for several product liability litigations involving metal-on-metal hip implants. This includes: Zimmer Durom Hip Cup Products, DePuy ASR hip implant products, DePuy Pinnacle hip implant products, Wright Medical Technology Conserve hip implant products, Biomet M2a Magnum hip implant products and Stryker Rejuvenate and ABG II hip implant products.
In metal-on-metal hip implant lawsuits, plaintiffs similarly allege that the devices are defective and caused injury due to its metal-on-metal design. Device makers allegedly knew about the risks but failed to warn plaintiffs or their physicians.
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).