Canada Recalls Stryker LFIT V40 Femoral Heads, Australia Issues “Hazard Alert”
Parker Waichman LLP comments that a new wave of metal-on-metal hip litigation could be on the horizon for Stryker, following reports of taper lock failure with its Stryker LFIT CoCr V40 femoral heads. The metal hip implant components were recalled in Canada, and regulators in Australia issued a “hazard alert” regarding the LFIT heads. Stryker has been involved with metal-on-metal hip litigation in the past following its recall of the ABG II and Rejuvenate hip replacements. The firm is closely monitoring Stryker metal-on-metal hip implant litigation and continues to offer free legal consultations to anyone with questions about filing a hip replacement lawsuit.
According to an Aug. 24 recall alert posted on Health Canada’s website, Stryker’s LFIT CoCr V40 Head and the CoCr, LFIT Femoral Heads are being recalled because the taper lock, the part of the hip implant that connects the femoral head (acts as the top of the thighbone) to the femoral neck, is failing more often than anticipated. The recall affects certain lots, the notification said. “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.”
Regulators in Australia also issued a warning regarding the Stryker LFIT metal-on-metal hip implant components. In a Sept. 27, 2016 “hazard alert” the Therapeutic Goods Administration of the Australian Government Department of Health website states “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.” Australian health regulators said the following could be signs of taper lock failure with the metal-on-metal device:
• loss of mobility
• adverse local tissue reaction
• joint instability
• broken bones around the components
• leg length discrepancy
• need for revision surgery
Orthopedic surgeons in Australia were informed of potential taper lock failure, the alert said. 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 ABG II and Rejuvenate Recall
Parker Waichman comments that Stryker has been involved in metal-on-metal hip litigation in the past. Lawsuits mounted following a 2012 recall of the Stryker Rejuvenate and ABG II modular-neck hip stems due to a risk of “fretting and corrosion” at the modular-neck junction. If fretting and corrosion occurs with the recalled device, the alert states, patients could experience adverse location tissue reaction (ALTR), pain and swelling at or around the hip joint.
Stryker advised surgeons to consider clinical examination on all patients implanted with the recalled ABG II and Rejuvenate, even if they did not experience these adverse events. To evaluate whether the hips shed high levels of metal debris, blood work may be considered. Cross section imaging could also be used to identify potential complications, Stryker said.
Rejuvenate and ABG II patients filed metal-on-metal hip replacement lawsuits alleging that Stryker failed to warn patients and their physicians about the potential complications. Alleged injuries include the need for an early revision surgery, ALTR, pain, swelling and other injuries. A revision surgery is when an operation is performed to remove the failed hip implant.
A Stryker hip implant settlement was reached in November 2014. The company agreed to resolve Rejuvenate and ABG II metal-on-metal hip implant lawsuits for $1.4 billion. The company settled lawsuits with plaintiffs who underwent a revision surgery, allegedly due to the defective design of the implants.
Metal-on-Metal Hip Implant Background
Metal-on-metal hip implant lawsuits have been on the rise in the past several years, particularly after DePuy Orthopedics launched a high-profile worldwide recall in 2010. The company said its ASR metal-on-metal hip implant was associated with higher than expected rates of failure. Generally, hip replacements are expected to last 10 to 15 years. The ASR, however, was failing in only a few years with a significant number of patients.
In a metal-on-metal hip replacement, all the components are made of metal as opposed to ceramic, plastic or a mixture of materials. A total hip replacement consists of an acetabular cup, acting as the hip socket, and the femoral component acting as the thighbone. When these components are made of metal and interact, there is a chance they can shed metal debris if the surfaces grind against one another. Metal-on-metal hip complications include pain, inflammation, tissue death and metal poisoning (metallosis).
The DePuy recall sparked personal injury lawsuits and questions about how metal-on-metal hip implants were approved. Following the recall, many metal hip makers were sued for metal hip devices. Stryker and Wright Medical are examples of device makers involved in metal hip litigation.
Plaintiffs in the litigation state that metal-on-metal hip implants were approved through 510(k). Devices cleared through 510(k) do not require manufacturers to submit data to show that their products are safe or effective; it was intended as a fast-track route for devices that are not considered to be high-risk, or Class 3. Metal-on-metal hip implants are labeled high-risk, but they were approved via 510(k) through a loophole, which temporarily allowed high-risk devices to be cleared without clinical data until the FDA made final determinations about device classification. Considering metal-on-metal hip implant problems and issues with other medical devices, critics have said that 510(k) is inappropriate for many medical products.
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, Rejuvenate 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).