Stryker Orthopaedics has voluntarily recalled certain lots and sizes of its LFIT Anatomic COCR V40 Femoral Heads, in light of the potential for the hip implant devices to fail prematurely, possibly putting patients at risk for serious injuries, including pain, inflammation, bone fractures, adverse tissue reactions, and the need for revision surgery. Patients who have been implanted with a recalled Stryker LFIT COCR femoral head have suffered debilitating pain, toxic levels of cobalt and chromium in their bodies, and other serious side effects caused by the defective medical devices. If you believe you have been adversely affected by a faulty Stryker LFIT COCR femoral head implant, contact a knowledgeable product liability lawyer today to discuss your legal options.
LFIT (Low Friction Ion Treatment) COCR (cobalt/chromium) V40 femoral heads are interchangeable, cobalt and chromium alloy, “ball” modular components manufactured by hip implant maker Stryker Orthopaedics. Stryker’s LFIT COCR femoral head was designed to restore stability in hips, reduce friction and wear, and prevent dislocation, compared to other hip replacement components, and the company fast-tracked the implant through the FDA’s 510(k) approval process, to be used with a variety of hip stems, including Stryker’s Accolade TMZF, the Accolade 2 Femoral Stems, the Meridian Femoral Stems, and the Citation Femoral Stems.
Total hip replacement systems are designed in such a way that multiple components fit together to form a complete joint, and when a new femoral stem is implanted, a femoral head must be placed onto the neck to complete the joint. It is at this so-called “taper lock” that Stryker’s LFIT COCR V40 femoral heads are failing, causing various problems, including allowing cobalt and chromium to be released into the tissue. This can result in serious problems, like metal blood poisoning, adverse local tissue reactions, chronic pain, and weakening of the device to the point of fracture.
Reports indicate that some LFIT COCR V40 femoral heads manufactured before 2011 are associated with a higher-than-expected rate of failures due to problems with the taper lock, which is the part of the implant that connects the femoral head to the femoral neck. According to Stryker, the LFIT components may be prone to taper lock failures due to inconsistencies with the taper lock interface, possibly putting patients at risk for the following injuries:
Stryker has received a higher-than-expected number of complaints regarding taper lock failures for specific lots and sizes of LFIT COCR femoral heads manufactured prior to 2011. According to reports, the cobalt and chromium heads of the Stryker femoral heads may corrode severely to the point that the head separates from the femoral stem, a problem known as “spontaneous dissociation,” which requires revision surgery to remove both the failed femoral head and stem. In other cases of Stryker hip implant failure, the devices have released toxic metal ions (chromium and cobalt) into the body, which can lead to a condition called metallosis, or metal blood poisoning. This side effect also requires revision surgery to remove the defective device and rid the body of toxic metals, to avoid systemic injury in patients. The Stryker hip implants believed to be prone to early failure include the following product numbers:
Orthopedic doctors who have implanted Stryker LFIT COCR femoral heads in patients have reported failures similar to those that led to the Rejuvenate and ABGII metal-on-metal hip implant recall issued by Stryker in 2012. This previous Stryker hip implant recall involved similar metal-on-metal hip implant issues relating to metallosis and premature failure of the artificial hip devices, and while this latest safety concern over the LFIT COCR femoral head involves failure at a different juncture of the modular implant, it has some similar characteristics in regards to the tissue and bone damage caused by the corrosive metallosis process. In many cases, failure of the Stryker hip implants results in the need for a second revision surgery to remove the device, which can result in severe pain, an additional risk of surgical complications, and a longer recovery time.
August 2012 – Diane Pingel and her husband file a lawsuit against Stryker, alleging that side effects of the Rejuvenate hip implant system caused her to suffer metal blood poisoning, bone death and a fractured femur requiring revision surgery.
November 2012 – Arkansas resident Tracy Sponer brings a complaint against Stryker after her Rejuvenate hip implant fails, forcing her to undergo painful revision surgery.
January 2013 – Cheryl Helder sues Stryker for “failing to use reasonable and due care,” after she undergoes two revision surgeries to remove Rejuvenate devices implanted in both her right and left hip.
June 2013 – All Stryker Rejuvenate and ABG II hip implant lawsuits are consolidated into a multidistrict litigation (MDL) in the U.S. District Court for the District of Minnesota.
May 2014 – Five lawsuits are filed in New Jersey, on behalf of patients who suffered serious injuries after being implanted with Stryker Accolade TMZF hip femoral stems and LFIT anatomic V40 femoral heads. The complaints allege that the hip implants were defectively designed and manufactured.
November 2014 – Stryker agrees to pay more than $1 billion to settle product liability lawsuits filed over defective Rejuvenate and ABG II hip implant devices.
July 2009 – Stryker issues a Class II recall for the Accolade TMZF femoral stem.
May 2011 – The FDA requires manufacturers of metal-on-metal total hip replacement systems to conduct postmarket surveillance studies of these devices.
June 2012 – The FDA convenes the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to “seek expert scientific and clinical opinion on the benefits and risks of metal-on-metal hip systems.”
July 2012 – Stryker recalls its Rejuvenate and ABG II hip implants over safety concerns, including metallosis and premature implant failure.
January 2013 – The FDA issues a safety communication indicating that “Metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants,” including damage to bone and/or soft tissue surrounding the implant and joint, caused by the release of tiny metal particles into the bloodstream.
January 2013 – The FDA issues a proposed order that requires makers of metal-on-metal total hip replacement systems to submit premarket approval applications for their medical devices.
September 2015 – Health Canada issues a recall for Stryker LFIT V40 Vitallium Femoral Heads manufactured between July 7, 2014 and August 15, 2014.
August 2016 – Stryker sends a letter to orthopedic surgeons, warning them about a “higher than expected” incidence of taper lock failure for certain LFIT COCR V40 femoral heads.
August 2016 – Health Canada issues a second recall for 36 mm, 40 mm, and 44 mm Stryker LFIT CoCr V40 femoral heads manufactured prior to 2011.
September 2016 – The Australian Therapeutic Goods Administration issues a Hazard Alert regarding the potential risks of 36 mm, 40 mm, and 44 mm Stryker LFIT CoCr V40 femoral heads manufactured prior to 2011.
The Medicines and Healthcare products Regulatory Agency (MHRA) issues an urgent field safety notice to all healthcare providers in possession of Stryker LFIT COCR femoral heads, indicating that the recalled devices should be quarantined pending return to the company.
Hundreds of thousands of artificial hip devices are implanted in patients every year, and while these devices are designed to last 15 to 20 years, in many cases, they are failing within two to three years after being implanted. Product liability lawsuits brought against Stryker for injuries allegedly caused by a defective LFIT COCR femoral head implant allege the following:
Despite the fact that regulatory agencies in other countries have issued safety alerts regarding Stryker’s LFIT COCR femoral head devices, the FDA has yet to issue a warning to patients implanted with the artificial hip components in the United States, although lawyers believe that a U.S. Stryker hip implant recall is imminent. If you have been implanted with a Stryker LFIT COCR femoral head, or if you have suffered serious injuries as a result of a defective Stryker implant, contact an experienced defective hip implant attorney today to discuss your options for legal recourse. With a qualified lawyer on your side, you can determine your next course of action, which may include filing a hip implant lawsuit against Stryker, in order to pursue the financial compensation you deserve for your injuries, medical expenses, pain and suffering, and other damages.