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June 25, 2018

Zimmer Hid Versys Hip Early Failure Risks to Increase Sales

A new product liability lawsuit against Zimmer Biomet, Inc. alleges that the company hid substantial Versys hip design defects that make the device prone to failure within a few years of implantation, resulting in debilitating complications and necessitating additional risky surgeries.

Versys Hip

Dorothy Coen and her husband, William, filed the complaint in the Southern District of Georgia on June 15. They indicate that the Zimmer Versys hip replacement is unreasonably dangerous, leading to pain, swelling, metallosis, trunnionosis, adverse local tissue reactions, and eventually the need for early revision surgeries. The Coens claim the problems come from corrosion, micromotion, fretting and other problems stemming from the product’s patently defective design.

Furthermore, they allege that Zimmer knew about these serious risks but concealed them from the public and medical community to protect profits at the cost of patients, forfeiting their health and lives for the sake of the all-mighty dollar.

“The Defendants knew of the subject products’ defective and unreasonably dangerous nature, as set forth herein, but continued to design, develop, manufacture, market, distribute, and sell the Zimmer Versys® Hip System so as to maximize sales and profits at the expense of the health and safety of the public, including Plaintiff, in conscious and/or negligent disregard of the foreseeable harm,” the lawsuit states.

Coen Zimmer Versys Hip Implant and Revision

During left hip replacement surgery, surgeons implanted Coen with a Zimmer Versys Hip System in July 2010. The hip system included a Versys 12/14 Taperd Cobalt-Chromium 36mm +0 femoral head, a size 13 Fiber Metal Midcoat Femoral Stem, a Longevity Poly Acetabular Liner, and a Trabecular Metal Cluster 50mm Shell/standard. However, it wasn’t long before Coen began suffering from incapacitating pain and hip function loss. A diagnostic imaging scan showed an enlarged soft tissue mass near the implant.

She finally underwent revision surgery to remove the implant on January 2, 2018. During the procedure, her surgeon, Dr. Shervin Oskouei, found necrotic muscle throughout the area. Dr. Oskouei further noted that there was a large amount of black corrosion around the hip implant’s neck taper.

“’This is one of the worst cases of muscular damage that I have seen intraoperatively,’” the lawsuit quotes Dr. Oskouei as saying of the extensive damage. Furthermore, the lawsuit claims that she will never fully recover from the wreckage that the hip implant has left behind.

Zimmer Versys Hip Design Defects

Coen’s claim indicates that the Zimmer Versys hip combines a taper threading system with cobalt-chromium femoral heads. This combination is more likely to produce wear and tear under fretting conditions. Her lawsuit notes that the taper treading is meant to protect optional ceramic heads. However, by allowing the use of metal heads, the design created substantial risk factors.

“Before it set out to design the Zimmer Versys Hip System, Zimmer knew of the dangers to human beings if cobalt-chromium metal debris from its products were released into the body through corrosion, micromotion, and/or fretting,” the lawsuit states. “Before placing the Zimmer Versys Hip System on the market, Zimmer was required to mitigate risks of the product, including any element of the design that created toxic levels of corrosion and debris that could result in pain, swelling, pseudotumor formation, osteolysis, instability, dislocation, metallosis, trunnionosis, adverse tissue reaction and/or the need for early surgical revision in patients-consumers.”

Metal Hip Lawsuits

Since metal-on-metal designs first emerged, a number of hip replacement recalls and issues have been associated with the defective implants. Additionally, there are serious concerns about the designs’ propensity to incite tumor growth and the potential risk of cancer this presents.

Following the DePuy ASR hip recall in August 2010, nearly 12,000 egregiously injured individuals stepped forward to take Johnson & Johnson to task for injuries and safety omissions similar to Coen’s. After several bellwether trials, J&J ultimately agreed to pay more than $2.4 billion to settle the DePuy ASR lawsuits.

Other similar metal hip implant lawsuits have also been filed over injuries from DePuy Pinnacle and Biomet Magnum, among others.

In August 2016, Stryker issued a recall for its metal LFit V40 femoral head. Consequently, a number of plaintiffs have filed lawsuits over the high rate of debilitating issues. The implant component is present in various different types of hip systems. These include Stryker Accolade, Stryker Meridian, Stryker Citation, and other of the company’s implants.

 

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