Product News and Recalls

Adverse Event Report Finds Fault with Zimmer Hip Implant Components

adverse event report filed over zimmer hip implantAn adverse event report submitted to the U.S. Food and Drug Administration (FDA) in December 2014 outlines safety issues with Zimmer trabecular metal primary hip prosthesis femoral stems. The report includes cases where patients who were implanted with the component experienced implant corrosion and aggravation to surrounding soft tissue.

While Zimmer is not currently facing any lawsuits over its trabecular metal primary hip prosthesis femoral stems, the Indiana-based company still has its hands full with Zimmer hip replacement lawsuits. These lawsuits have been filed by patients who allege that the Zimmer Durom Acetabular Component, or Durom Cup, was defectively designed and is prone to dislocation or deterioration inside the body. The Durom Cup can release toxic metal particles into the bloodstream due to abrasion of its metal components. This can cause metallosis, a condition known to cause fatigue, dizziness, and extreme pain. Metallosis may also necessitate revision surgery, which can be costly and painful.

The adverse event report concerns 15 Zimmer femoral stems that were implanted in patients who had metal-on-polyethylene total hip replacement systems and who later were diagnosed with mechanically assisted crevice corrosion, or MACC. According to the report, MACC is defined as “having new onset otherwise unexplained pain and elevated serum cobalt levels of 1.6ng/ml or greater.” In other words, the patients examined were suffering from a higher concentration of chromium in the bloodstream, which can cause various severe health issues, such as cardiomyopathy, nerve damage, visual impairment, and implant loosening.

Since they were implanted with the Zimmer devices, six of the patients have undergone revision surgery, which involved removal of the component. All of the patients who had the Zimmer device removed were found to have visible corrosion at the head–neck junction of the hip replacement system. Additionally, some degree of pathological harm to the surrounding soft tissue was discovered in all patients who underwent revision surgery. The report suggests that the MACC was a result of abrasion in the metal–metal modular junctions of the total hip replacement systems, of which the Zimmer femoral stems were a part.

If you or someone close to you was injured by a failed Zimmer hip replacement system or implant component, contact Lopez McHugh today to speak free of charge with one of our talented hip replacement lawyers. You may be eligible to receive damages through your own Zimmer hip replacement or hip implant lawsuit.