Wright Profemur Hip Implants Cause Metal Poisoning And Other Side Effects
Wright’s Profemur hip replacement system was created to provide patients with a custom-fitted hip joint, allowing them better mobility after surgery. The device has six interchangeable neck pieces in multiple lengths that can be fitted onto the stem to fit patients of all shapes and sizes, especially those undergoing complex revision surgeries. Unfortunately, this modular design has a metal stem and metal neck components, causing complications that have been proven to increase the risk of early failure.
Common Side Effects of the Wright Profemur Hip Replacement
Although it was meant to help patients recover from difficult surgeries, the Profemur’s high failure rate quickly led to a Class 1 FDA recall. The FDA’s recall of the Profemur Neck Varus/Valgus CoCR warned patients of the risks of “serious adverse health consequences” due to corrosion of the device, rubbing together of the metal components (fretting), and femoral neck fractures. These defects have led to a number of injuries, including:
- Early replacement. Most hip devices are created to last ten years or more, but premature failure of the Profemur has resulted in revision surgery just a few years after implantation.
- Bone fractures. Metal devices place strain on a patient’s hip bones, making it more likely the pelvis will fracture. Bone fragments may break loose and migrate throughout a patient’s body, causing bleeding complications such as hematoma or hemorrhage. Patients will often require surgery to remove bone fragments.
- Pseudotumors. Metal devices are more likely to encourage tissue growth along the implant. This buildup of organic material, known as pseudotumors, can limit mobility and cause pain in the hip joint.
- Impaired mobility. Even if no other ill health effects occur, patient may still suffer debilitating swelling and pain in their hips and legs as the device becomes loose. This can force patients to be less active, hear crunching or popping noises in the hip joint, or suffer a limp or inability to walk.
Wright Profemur Patients May Suffer Metal Poisoning
One of the most worrying side effects of metal-on-metal hip devices is metallosis, or metal poisoning. Fretting causes microscopic particles of metal to be released into the bloodstream, causing heavy metals from the device to be absorbed into a patient’s bones and organs. It can take years for symptoms to become evident, and may cause permanent health effects.
Metal poisoning has been associated with the following symptoms:
- Chest pain, wheezing, coughing, or shortness of breath
- Numbness or tingling in areas throughout the body
- Difficulty seeing, blurry vision, or trouble hearing
- A persistent feeling of being tired or “worn out”
- Mental confusion, forgetfulness, or disorientation
- Shivering or feeling cold
- Sudden or inexplicable weight gain
- Problems with urination
Why Are So Many Metal Hip Implants Causing Injuries?
Many defective hip devices were originally approved under an FDA process known as the 510(k) program. This allows device manufacturers to get faster approval if the device they have made is similar to a device that has already been approved by the FDA and has been released onto the market. Not only does the 510(k) process not require the same safety trials as standard approval, new products are often compared to formerly-approved devices that are flawed or have even been removed from the market, such as other harmful metal-on-metal hip devices.
One such product is the Profemur Z Revision Hip Stem, which was approved as a “substantially equivalent” device under the 510(k) process in 2012. Over 8% of patients who received a Profemur Z stem suffered early failure of the device that resulted in revision surgery—a risk three and half times higher than similar devices. In recent years, patients have filed Profemur lawsuits against Wright Medical, many of which claim that the company was aware of serious risks to patients.