The U.S. Food and Drug Administration (FDA) has issued a Class I recall of a Zimmer hip implant component used in hip replacement systems. The M/L Taper with Kinectiv Technology Femoral Stems and Necks is a Tivanium alloy device is used by surgeons to fit hip replacement systems to individual patients.
According to the FDA notice, the Zimmer devices were recalled due to higher-than-expected levels of manufacturing residues resulting from a process monitoring failure. The built up residues can cause serious health problems for patients implanted with the device, including allergic reactions, pain, infections, and death. Furthermore, patients exposed to the contaminated implant components may need to undergo revision surgery to fix the hip replacement system, which can be very costly and painful.
The Indiana-based medical device manufacturer already has its hands full with hip replacement lawsuits filed over its Durom Acetabular Component, or Durom Cup. Plaintiffs in Zimmer hip replacement lawsuits claim that the Durom Cup was defectively designed and is prone to deterioration and dislocation inside the body. Furthermore, the metal-on-metal design of the implant can result in toxic metal particles being released into the bloodstream. These metal ions can build up in the soft tissues of the body and lead to metallosis, which is known to cause fatigue, dizziness, and extreme pain.
On top of its hip lawsuit troubles, Zimmer also recently had to recall thousands of Persona knee implants due to dangerous product defects. Patients complained of loosening of the implant and radiolucent lines—gaps between the components of the device or between the device and the bone that can result in severe pain, inflammation, and bone damage. The Persona knee implant recall came less than a year after Zimmer recalled over 40,000 of its NexGen MIS Tibial knee implant components last June.
The Persona knee recall was a Class II recall; this time, Zimmer has issued a Class I recall of its M/L Taper with Kinectiv Technology Femoral Stems and Necks. Class I recalls are the most serious type of recall, issued only when there is a reasonable probability that the products will result in serious adverse health consequences or death for the patient.
The lawyers at Lopez McHugh are dedicated to protecting patients and consumers from faulty medical products. We understand how painful and expensive revision surgery can be. If you or a loved one suffered due to a defective Zimmer hip implant or hip implant component, you should call the hip replacement attorneys at Lopez McHugh for a free legal consultation.