FDA Recalls Profemur Cobalt Chrome Neck – Kiesel Law LLP Files the First Case Against Device Manufacturer Wright Medical

Wright designed and manufactured the now recalled PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254, a component of the company’s PROFEMUR Hip System. The recalled device was distributed from June 15, 2009, to July 31, 2015. After releasing the device, Wright sold its hip division, OrtoRecon, to MicroPort Orthopedics Inc. in January 2014. MicroPort continued to distribute the device until the device’s recall.

When the FDA issued a Class 1 hip replacement recall of the PROFEMUR Long Cobalt Chrome neck component, it advised patients to seek immediate medical treatment if they experience any sudden onset of severe pain in their post-operative hip, difficulty or inability walking, significant trauma to their hip or leg (e.g. falling), or a tingling sensation or loss of feeling in their leg. The FDA cautions that if the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking and performing common tasks. An acute fracture will require revision surgery to remove and replace the neck and stem components. Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, and even death.

Kiesel Law LLP, committed to halting the sale of defective medical devices, filed the first case against Wright for injuries caused by the PROFEMUR Long Cobalt Chrome neck component, and also handles cases involving the Wright Profemur-Z titanium hip system. If you have undergone a hip replacement surgery in which you believe the PROFEMUR Long Cobalt Chrome neck or Profemur-Z titanium neck was utilized, please contact our firm for a free consultation.