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According to allegations raised in a product liability lawsuit filed this month against Zimmer Biomet, Inc., problems with the design of the Versys hip replacement make the device prone to fail within a few years, resulting in painful complications and the need for risky revision surgery.
In a complaint (PDF) filed in the U.S. District Court for the Southern District of Georgia on June 15, Dorothy Coen and her husband, William, indicate that the Zimmer Versys hip implant carries unreasonable risks of pain, swelling, metallosis, trunnionosis, adverse local tissue reaction and the need for early revision surgery. The lawsuit suggests the problems arise from corrosion, micromotion, fretting and other problems.
Coen indicates that she was implanted with a Zimmer Versys Hip System in July 2010, during left hip replacement surgery. The system included a Versys 12/14 Taperd Cobalt-Chromium 36mm +0 femoral head, a size 13 Fiber Metal Midcoat Femoral Stem, a Trabecular Metal Cluster 50mm Shell/standard, and a Longevity Poly Acetabular Liner. However, following implantation, Coen began suffering increased pain and loss of hip function. A diagnostic imaging scan revealed that she had an enlarged soft tissue mass in the region of the implant.
Coen underwent revision surgery to have the implant removed on January 2, 2018, during which the surgeon found necrotic muscle throughout the area, indicating “this was 1 of the worst cases of muscular damage that I have seen interoperatively” and noting that there was a large amount of black corrossion around the neck taper.
After the surgery, Coen had to have an antibiotic spacer implanted to fight an ongoing infection.
The lawsuit indicates that the Zimmer Versys hip design combines a taper threading system and the use of cobalt-chromium femoral heads, which is more likely to produce wear and debris under fretting conditions. The lawsuit notes that the taper threading was meant to protect the optional ceramic heads, but by allowing the use of metal heads, the design created an unreasonable risk.
“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.”
Coen presents claims of unreasonably dangerous design, failure to warn, manufacturing defect, negligence, negligent misrepresentation, breach of warranty and consumer fraud. She seeks both compensatory and punitive damages.
Metal-on-Metal Hip Litigation
In recent years, a number of hip replacement recalls and problems have been associated with metal-on-metal designs. In addition, some concerns have been raised about the development of tumors and a potential risk of cancer that may be associated with the design.
Similar allegations were raised in nearly 12,000 DePuy ASR hip lawsuits filed against Johnson & Johnson, after their metal-on-metal implant was recalled in August 2010. Following several bellwether trials, the manufacturer ultimately agreed to pay more than $2.4 billion to settle the DePuy ASR litigation.
More recently, a number of claims have followed a Stryker LFit V40 recall issued due to a high rate of problems experienced by individuals who received the femoral head used in various different types of hip systems, including Stryker Accolade, Stryker Meridian, Stryker Citation and other implants.