Stryker LFIT CoCr V40 Femoral Heads Recalled in Canada, “Hazard Alert” Issued in Australia
Regulators in Canada and Australia recently took action regarding a metal-on-metal hip implant component, the LFIT CoCr V40 Femoral Heads. Metal-on-metal hip implants have been the subject of numerous personal injury lawsuits for various device makers, including Stryker Orthopaedics. The company faced a flood of lawsuits after recalling its Rejuvenate and ABG II recall in 2012. Parker Waichman LLP is investigating potential lawsuits on behalf of individuals implanted with the Stryker LFIT CoCr V40 Femoral Heads. The firm has represented numerous clients in metal-on-metal hip implant lawsuits.
Now, another Stryker metal-on-metal hip implant is being recalled in Canada. According to an Aug. 24, 2016 alert posted on Health Canada’s website, the LFIT COCR V40 Head and the COCR, LFIT Femoral Head were recalled because “Stryker has received higher than expected complaints of taper lock failure for specific lots of certain sizes of LFIT Anatomic COCR V40TM Femoral Heads manufactured prior to 2011.” The hip implant part has not been recalled in the United States.
In Australia, regulators issued a “hazard alert” warning of taper lock failure with the LFIT CoCr V40 femoral heads. In a Sept. 27, 2016 notification, the Therapeutic Goods Administration of the Australian Government Department of Health stated “that some LFIT Anatomic CoCr V40 femoral heads manufactured before 2011 have a higher than expected incidence of taper lock failures. The taper lock is the part of the implant that connects the femoral head to the femoral neck.”
The hazard alert cautioned that, if taper lock failure occurs, patients may experience the following side effects:
• loss of mobility
• adverse local tissue reaction
• joint instability
• broken bones around the components
• leg length discrepancy
• need for revision surgery
Stryker notified orthopedic surgeons of the risks. Possible complications associated with taper lock failure include dissociation of the femoral head from the hip stem, fractured hip stem trunnion, increased metallic debris, insufficient range of movement, insufficient soft tissue tension, noise from the implant, loss of implant, bone fixation strength, increased wear debris and implant construct with a shortened neck length.
Stryker Rejuvenate and ABG II Recall, Lawsuits and Settlements
Stryker recalled metal-on-metal hip implants in June 2012, citing a risk of “fretting and corrosion” at the modular-neck junction with its Rejuvenate and ABG II modular-neck hip stems. The company warned that fretting and corrosion may lead to adverse location tissue reaction (ALTR), pain and swelling at or around the hip joint. Surgeons were advised to consider a clinical examination of all patients implanted with the recalled metal-on-metal hip implant, regardless of whether they are experiencing symptoms, the recall alert noted. Doctors may also want to perform blood work and cross section imaging, the company said.
Following the recall, a number of personal injury lawsuits were filed over the Stryker Rejuvenate and ABG II metal-on-metal hip replacements. Patients alleged that the faulty hip devices led to ALTR, pain, swelling and the need for an early revision surgery to remove the failed implant. Plaintiffs alleged that Stryker designed the hip implants defectively and failed to disclose the risks to patients and their physicians.
In November 2014, Stryker agreed to pay $1.4 billion to settle Rejuvenate and ABG II lawsuits. The settlement resolved lawsuits filed by patients who had revision surgery to replace the recalled hip implant.
Metal-on-Metal Hip Implant Background
In metal-on-metal hip replacements, all contacting surfaces are made of metal. A total hip replacement consists of an acetabular cup, meant to replace the socket of the hip, and a femoral head and neck meant to replace the femur bone. These components interact with each other to mimic the natural motion of the hip. The concern with metal-on-metal hip implants is that they can release metal debris when the metal surfaces rub against one another.
The shedding of metal ions into the body can lead to various complications, including pain, inflammation, difficulty walking, implant loosening, dislocation and metal poisoning (metallosis). When these adverse events become severe, patients are sometimes forced to undergo a revision surgery to remove the failed implant. Hip replacements are expected to last a decade or more, but recalls suggest that they can be prone to early failure.
Concerns of over metal-on-metal hip implants gained media attention in August 2010, when DePuy Orthopaedics issued a worldwide recall of its ASR metal-on-metal hip implant. The hip devices were recalled due to a higher than expected rate of failure, with some patients needing to undergo a revision surgery in a few short years. DePuy is also facing lawsuits over the metal-on-metal version of its Pinnacle hip implant.
Plaintiffs in the metal-on-metal hip litigation have similar allegations alleging that the all-metal design of the hip device caused injuries and usually, the need to undergo an early revision surgery. Lawsuits also allege that the manufacturer failed to disclose the risks to patients and the medical community. Plaintiffs point out that metal-on-metal hip implants were approved through 510(k), a regulatory process that allows certain devices onto the market without clinical test for safety or efficacy if the device maker can show that the device is “substantially equivalent” to a previously approved product (known as a “predicate”). Critics say that the 510(k) route essentially served as a regulatory loophole for manufacturers to expedite approval. This route is only intended for devices that are not classified as “high-risk”, or Class III.
Thousands of personal injury lawsuits have been filed against metal-on-metal hip implant manufacturers, including Stryker and DePuy. Parker Waichman LLP is a national law firm that is well-versed in metal-on-metal hip litigation. Our attorneys offer free legal consultations for individuals who want to know more about filing a medical device lawsuit.
Legal Help for Stryker Metal-on-Metal Hip Implant Recipients
Parker Waichman has years of experience representing clients in numerous metal-on-metal hip implant lawsuits. If you or someone you know was implanted with a Stryker metal-on-metal hip implant such as the Stryker ABG II or the LFIT, you may have valuable legal rights. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).