Smith & Nephew Tandem Bipolar Hip Implant Recall and Lawsuits

Tandem Bipolar Hip System Recall is Class 2

Smith and Nephew is issuing a Class 2 recall for its Tandem Bipolar Hip System because it can detach after surgery. The U.S. Food and Drug Administration (FDA) has labeled the recall as Class 2, meaning the recalled device can reasonably lead to temporary or medically reversible injuries. Class 2 recalls also indicate situations where the risk of serious injury is remote. Smith and Nephew launched the recall in August 2016.

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.

Smith and Nephew recalled the Tandem Bipolar Hip System because “some Bipolar shells were manufactured with an out-of-specification retainer groove,” the recall notification states.

The Tandem Bipolar Hip implant was also recalled in Australia. In a “hazard alert”, the country’s health regulatory agency cautioned that the defective 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.”

Parker Waichman notes that Smith and Nephew has recalled other hip implant systems recently as well. The company issued three Class 2 recalls for the Modular Redapt Hip System, the Modular SMF Hip System, and Modular Necks “due to a higher than anticipated complaint and adverse event trend.” In total, 32,000 devices are affected by the Modular hip system recall.

In a letter to physicians, 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,”
Adverse events associated with the recalled Modular systems include pain, swelling, limited mobility, and an enlarged bursa. Doctors may want to test patients for increased levels of cobalt or chromium ions, Smith and Nephew said. The presence of metal ion levels over 7 parts per billion “may indicate the potential for soft tissue reaction,” the company said.

“The need for any additional follow-up should be determined on an individual case-by-case basis following an assessment of patients’ clinical circumstances,” Smith and Nephew stated. “Revision surgery should only be considered after a comprehensive examination of all the clinical findings, including blood work, imaging and especially if an adverse soft-tissue reaction is confirmed,”

Lawsuits Filed over Smith & Nephew BHR, R3 Metal-on-Metal Hip Implants

Smith and Nephew is already facing lawsuits alleging injuries from its metal-on-metal Birmingham Hip Replacement (BHR) system and R3 Acetabular System. As with other lawsuits filed over metal-on-metal hip implants, plaintiffs allege that the devices are defective and cause adverse events by releasing metal particles into the bloodstream and nearby tissues. Plaintiffs allege that Smith and Nephew was aware of the risks but failed to warn patients or their physicians.

Smith and Nephew withdrew the BHR in 2015 and recalled the R3 in 2012. Plaintiffs in the litigation allege that the metal-on-metal hip implants cause injuries such as pain, inflammation, bone damage and metallosis (metal poisoning).

According to court records, plaintiffs in the litigation are seeking a federal multidistrict litigation (MDL) for Smith and Nephew BHR and R3 hip implant lawsuits. In an MDL, lawsuits with common questions of fact are consolidated to one court before one judge. Transferring lawsuits in this manner helps make complex litigation more efficient because it avoids duplicate discovery and other pretrial proceedings.

Metal-on-metal hip implants have raised safety concerns because they can release metallic debris when the surfaces of the device rub against one another. Several device makers have faced product liability litigation over metal-on-metal devices, including DePuy Orthopedics, Wright Medical, Zimmer, Biomet and Stryker.

The 510(k) was used to approve the Modular Hip systems, Tandem Bipolar hip systems and metal-on-metal hip implants in general. When devices are cleared through 510(k), it means that manufacturers only need to show that the device is “substantially equivalent” to a previously approved product. Substantial equivalence means that a device is just as safe as an older product (called a predicate).

Plaintiffs in the metal-on-metal hip implant litigation allege that the defective nature of the device leads to implant failure, forcing patients to undergo an invasive and painful revision surgery to remove and replace the device. Hip implants are expected to last 10 or 15 years, but lawsuits allege that plaintiffs had to undergo a revision surgery much sooner due to complications.

One plaintiff filed a recent BHR lawsuit against Smith and Nephew. According to the complaint, the metal-on-metal hip implant failed after only eight years.

To address safety concerns, the FDA gathered a panel of experts in 2012. The experts said there are “unique risks” with metal-on-metal hip implants. “In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an ‘adverse local tissue reaction (ALTR)’ or an ‘adverse reaction to metal debris (ARMD),” according to the FDA.

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).

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