We recently wrote about medical device litigation involving some defective hip replacements; specifically, the Smith & Nephew Birmingham Hip Resurfacing System (BHR) device. Another lawsuit that is starting to pick up some steam involves Zimmer M/L Taper with Kinectiv© Technology Hip Implant System.
This emerging lawsuit appears to be another example of a medical device cleared by FDA’s 510(k) process that has failed after being marketed.
Hip implants generally have several functioning pieces, one of which is called “the head.” The head used by Zimmer in these specific devices have either been a cobalt-chromium femoral head or a ceramic femoral head. Plaintiffs have been suing Zimmer alleging the cobalt-chromium femoral head created an unreasonable risk of injury.
Specifically, this medical device is alleged to present an unreasonable risk of pain, swelling, metallosis, adverse local tissue reaction, and trunnionosis. Trunnionosis is defined as “wear of the femoral head-neck interface and has recently been acknowledged as a growing cause of total hip arthroplasty failure,”1 and often occurs due to corrosion, micromotion, fretting or other mechanisms. When it does, patients have to undergo a “revision surgery” earlier than typically expected. Revision surgery is when the doctor removes an older or faulty medical device to replace it with a functioning replacement or newer model.
Medical devices like the hip implant are not intended to last forever, but there is a reasonable expectation that they should function for at least a decade, if not more Unfortunately, because of the design of this Zimmer device – the type of metal used and other factors – they are failing sooner than that, causing patients to have more revision surgeries than expected. Patients who have had the Zimmer M/L Taper with Kinectiv© Technology Hip Implant System across the country are suing the manufacturer. One of their claims, if properly designed from the beginning, patients using these Zimmer hips devices could have avoided excessive revisions surgeries and unnecessary pain.
Zimmer, Inc. is a registered Delaware corporation, with its principal place of operations located in Warsaw, Indiana, which engages in the design, research, development, manufacturing, and marketing of orthopedic reconstructive implants and related surgical products – including the hip device mentioned earlier.
We believe that Zimmer, Inc. designed, manufactured, and marketed this device despite knowing it presented a danger to human beings if the cobalt-chromium metal debris present in the device ever released into a patient’s body through corrosion, micromotion, fretting, etc.
As explained on our medical device practice area page, before marketed to physicians and patients, companies must mitigate foreseeable risks of their devices. That includes elements of a hip medical device that could produce toxic levels of corrosion and debris, causing patients pain, swelling, pseudotumor formation, osteolysis, instability, dislocation, metallosis, trunnionosis, adverse tissue reaction. Without adequately examining those risks,
Zimmer marketed the Zimmer M/L Taper with Kinectiv© Technology Hip Implant System to be “implanted in a wide variety of patient types,” including “younger patients; elderly patients; and hip fracture patients.” Zimmer M/L Taper Hip Prosthesis with Kinectiv © Technology, 97-7713-001-00 Rev. 2 1012-H16 7.5ML, 2007. Zimmer failed to conduct the proper clinical trials and pre-marketing testing and then after risks emerged, Zimmer neglected to disclose them, something that happens too often in this industry.
The conduct described in this post constitutes negligence, but plaintiffs have sued Zimmer under various other theories of liability. Plaintiffs will bring claims based on the product’s defective design, including the choice of using metal, and the manufacturing process of the device is alleged to cause severe injuries and is another way of holding Zimmer accountable for their actions.
Zimmer failed to conduct necessary actions it should have done, and they knowingly made choices it should not have. They did not test, they did not warn, they chose designs that were dangerous, and they effectively ignored the risks their device presented. Those actions and omissions hurt people and therefore constitute gross negligence.
KBA continues investigating these cases and other claims of defective medical devices. If you have had a hip implant and suffer from pain, swelling, pseudotumor formation, osteolysis, instability, dislocation, metallosis, trunnionosis, or an adverse tissue reaction, contact us and let us see if we can help.
References
J Orthop Traumatol. “Trunnionosis in total hip arthroplasty: a review”, US National Library of Medicine
National Institutes of Health, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4805640/. Accessed DATE.