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Have you had hip replacement prior to 2012? Medical device manufacturer, Stryker, has acknowledged V40 heads in their hip replacements manufactured prior to March 4, 2011 have an increased failure rate for head/hip stem dissociation. Stryker V40 heads were distributed to health care professionals relatively close the manufacturing date.
In 2016, Stryker issued an extended recall on metal head, hip implants to include anatomic LFIT V40 heads with catalog numbers beginning “6260 -9”. More specifically, product safety notifications sent to health care professionals May 22, 2018 was an extension of the prior recall that primarily affected the size 40 and size 44mm V40 heads. The specific catalog numbers, head diameters, and offset data of effected devices are contained in the following chart:
We believe the defective nature of this component is not confined to the expansion of this list and others are still at risk
Full notification: Expanded Product Safety Notification
In review of records and other information, the V40 made of Cobalt and Chrome (CO/CR) are worth investigating for a potential claim. This is especially true if the stem is on the earlier version Accolade TMZF stem. We do not think hip implants with ceramic heads will be viable claims.
July 2017: Breaking News Update To Cover Stryker LFIT V40 Femoral Head Recall
In our continued representation of Stryker hip clients into 2017, we find that our clients are hungry for information regarding the Stryker hip implant recalls and the health effects associated with these recalled devices. Unfortunately, we are finding that many patients are unhappy and often unable to get answers to questions they have from their surgeon and other trusted sources in order to evaluate their need for monitoring and/or revision surgery.
To that end, we have devised the Top 10 Things All Stryker Hip Implant Patients Need To Know to further address many of the common questions we are asked. We sincerely hope this information will help better inform those affected by the Stryker Rejuvenate and ABG II Modular-Neck Stem hip implant recall or the LFIT V40 metal femoral head recall commonly used on Accolade Stems and further make everyone aware of both their medical and legal options.
On November 9, 2016, the FDA announced certain lots of the Stryker LFIT V40 Femoral Head (metal) that were manufactured as early as 2006 by Stryker were being recalled. Stryker initiated the recall on or about August 29, 2016. These are some of the affected hip implant lots. The LFIT V40 femoral heads are known to be utilized on both Accolade TMZF and Accolade 2 stems as well as Meridian and Citation stems.
Dangers from these failures Stryker V40 LFIT implants include: Disassociation of femoral head from hip stem, fracture of the stem, corrosion of the trunnion, excessive metallic debris and numerous other complications caused by corrosion at the connection between the head and stem ( trunnion). Recent published surgical studies have shown symptoms and failures of these metal heads even in lots not covered in the affected Stryker recall. An example of one such study that examined 30 implants of 28 patients can be found here. Experts that we have consulted with tell us the LFIT V40 femoral head is made of cobalt and chrome, which when matched with the Accolade TMZF stem, specifically causes the need to monitor ones levels. This mix metal combination of titanium with cobalt and chromium results in wear and/or corrosion post implant.
Previously on July 6, 2012 – Stryker announced it had voluntarily recalled its Rejuvenate and ABG II modular-neck stems. The issue stems from mechanically assisted corrosion and release of metal ions of Cobalt and Chromium that affect surrounding tissue and bone over time. The company was non-specific in its press release as to the exact reason or failure rate.
“While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action,” said Stuart Simpson, Vice President and General Manager, Hip Reconstruction.
Stryker’s Rejuvenate Modular system was approved by the Food and Drug Administration (FDA) in June 2008. The ABG II system received FDA approval in November 2009. The earliest implanted devices that we have seen were in late 2010 because of the timing to distribute and market the new product to physicians.
You may be having pain around your hip, difficulty walking, inflammation or other symptoms. You may even have head-neck dissociations that are extremely painful. Your physician has the ability to evaluate you to determine if you are at a greater risk of injury or complication. The inflammatory response from the metal sometimes occurs with little or no symptoms until there is harm to the surrounding tissue and loss of bone. An early X-ray is decent way to examine the bone and device placement but an MRI often provides more specific information. Without an MRI a patient may not recognize the harms that may be occurring until they develop symptoms. (Aspiration from the joint or blood work to measure the metal ion levels is a telling sign of medical complications). Your orthopedic surgeon can help you with these matters. Call their office to discuss your plan of care and treatment if you have not already done so recently.
Cobalt is one of the many metals that is found naturally in the body, but as is common with most all metals, levels in excess can become toxic and lead to many harmful and potentially harmful side effects. Cobalt poisoning has caused cardiomyopathy, hypothyroidism, and neurological damage as well as impairing the sense of sight and hearing. As far as the recalled hip implant devices go, excess amounts of cobalt in the bloodstream lead to inflammation which can seriously damage surrounding tissue and bone.
If the Doctor does not independently research studies regarding toxic values of Cobalt, patients will likely not be informed if the level of cobalt present in their blood is actually elevated, or even toxic, thereby subjecting them to prolonged issues and injuries.
Here are the overall guidelines issued January 17th on the FDA website that I believe will now become standard of care.
Safety Communication:
http://www.fda.gov/ MedicalDevices/ Safety/ AlertsandNotices/ ucm335775.htm
Information about Imaging and Metal Ion Testing
That is a question for your physician but the evaluation must weigh the cost/benefit analysis. [Potential harms of removing the device vs. that of replacing it all together]. Many factors such as one’s age, health, weight and other risk factors must be carefully considered. See your orthopedic surgeon to discuss this potential problem and other avenues of treatment to see what is best for you and your family. You will often find that surgeons experienced with the harms from the recalled Stryker hip implant devices may not be the same surgeon that put in the device. You may also want to get a second opinion and ask what components are going to be utilized and if the physician is limited by contract or experience to a certain manufacturer. Experience related to these modular components matter. Stryker in 2012 even has released an extraction protocol for the benefit of the surgeon related to the Rejuvenate/ ABG2 stem removal. http://literature.ortho.stryker.com/files/LSP70.pdf
As of the time of publishing this blog, Stryker has yet to inform or issue a bulletin to health care professionals on the relative risk, notification and treatment of patients with LFIT V40 Cobalt Chrome CO/CR metal heads. Patients may be at risk for corrosion between the CO/CR femoral head and titanium stem that have not been notified or tested.
For a free no obligation consultation about your Stryker V40 LFit, Stryker Rejuvenate or ABGII hip implant recall, contact the hip implant recall lawyers at Childers, Schlueter & Smith, LLC. You can call us toll free at 1-800-641-0098, chat with our live team via the chat feature, or send us a confidential email to intake@cssfirm.com
There are risks to having any type of surgery but knowing more about the procedure and how to deal with it is key. This is a very painful and complicated procedure. A second hip surgery is usually longer and more intense than the first and not all patients are candidates for a revision surgery. Only a trained medical doctor can make this determination with you after conducting the requisite blood tests, x-rays, MRIs and other medical examinations.
Broadspire was announced to have been hired by Stryker on or about January 3, 2013. According to reports, Broadspire is a division of Crawford and Company that is touted as the world’s largest insurance and claims adjuster. Broadspire is funded by Stryker to gain access to the medical records of patients affected by Stryker’s recall of the Rejuvenate/ABG2 modular stems through medical authorizations. There can be a benefit to the uninsured patient seeking reimbursement for medical expenses or gaining approval to have expensive procedures paid for by the company, but keep in mind that making a claim for out of pocket expenses or medical bills not paid for by insurance is all that Broadspire is really doing based on our findings.
If your claim is not filed in a civil action (Stryker hip lawsuit) before the expiration of the statute of limitations, you will not be able to pursue a claim for the harms that you have experienced, or may experience, in the future. These include but not limited to pain and suffering from the recalled Stryker hip implant.
Unfortunately, as of the time of publishing updates to this post, Stryker has not offered a program to reimburse or pay for procedures caused by the failures of the LFIT v40 femoral head.
One common question many patients have is what responsibility, if any, do the doctors and/or orthopedic surgeons that implanted these devices have in this nationwide Stryker hip implant recall. Our firm’s research and findings are clear: NONE in the cases we have seen and reviewed to date. Stryker has failed to provide information prior to implantation of the increasing failure rates of Stryker Rejuvenate /ABG II Modular-Neck Stems, and LFIT v40 metal heads. Stryker made and marketed the device to your surgeon. Had your surgeon known in hindsight of the problems created by these products, your surgeon likely would not have utilized them. Thus we see this as a product liability issue, not one of medical malpractice.
Along with the medical costs from eventual hip replacement revision, a failed hip replacement can cause a lot of other hardships, including effects on the patient’s lifestyle. Too many patients with defective Stryker hip replacements struggle through extensive rehabilitation therapy in order to pursue a more active life after the hip replacement implant only to have their daily activities slowly restricted again once the Stryker systems began to manifest problems. For this and other reasons, the representation of our hip implant clients is on an individual one-on-one basis.
We are NOT representing folks in a class action basis, nor do we believe it would be in your best interest to be in a class action.
Our firm is committed to zealous and effective representation of clients who are affected by the Stryker V40 LFIT, Stryker Rejuvenate and Stryker ABG II devices for all harms associated with this recalled device.
Stryker claims it will cover reasonable and customary costs of monitoring and treatment on the Stryker Rejuvenate and Stryker ABG II, but in reality, Stryker’s intentions may not be so transparent. Stryker has requested that patients submit all of their bills to private health insurance (including Medicare and employer sponsored – ERISA – health insurance plans), offering only to pay the patient’s out-of-pocket co-pays and deductibles. This is an excellent deal for Stryker, but it is not justice for the patient or your health insurance carriers who are in essence paying for Stryker’s mistakes.
A jury can consider the following list concerning non-economic factors for the Stryker LFIT V40 Femoral Head, Stryker Rejuvenate and ABG II Modular-Neck Stem hip replacement recall lawsuit:
1) Any lost wages or loss of earning capacity;
2) The effect the Stryker hip injury had on the individual’s overall mental and physical well-being;
3) The duration and extent of the injury the individual suffered;
4) The mental anguish and pain suffered by the individual;
5) The amount of past or future medical expenses was caused by the defective Stryker LFIT V40 Femoral Head, Stryker Rejuvenate and ABG II Modular-Neck Stem hip replacement implants;
6) The extent of any disfigurement or any scarring that was caused by the defective Stryker LFIT V40; Stryker Rejuvenate and ABG II Modular-Neck Stem hip replacement implants.
You should ask an attorney about this question. Our position is that you should retain the hip implant hardware with an approved medical device retrieval company per an agreed protocol. We have retained a company that works directly with the hospital and surgeon in having the device preserved for any subsequent testing and/ or failure analysis. This is a very important decision because the removed hardware will become critical evidence in your claim against Stryker in the days ahead. It is your hardware because you or your insurance company paid for it so do not let anyone tell you anything to the contrary. If you have questions about the retention of your implanted hardware give us a call as we are happy to help.
For a free no obligation consultation about your Stryker LFIT V40 Femoral Head Stryker Rejuvenate or ABGII hip implant recall, contact the hip implant recall lawyers at Childers, Schlueter & Smith, LLC.
Our firm is experienced in making successful claims for hip patients throughout the United States and also serves in National Leadership by Appointment and Court Order to the Plaintiff Steering Committees in Federal court in the Stryker ABG2/Stryker Rejuvenate Litigation and the Stryker LFIT V40 litigation before the Honorable Donovan Frank of the United States District Court of Minnesota in MDL 2441 and the Honorable Indira Talwani of the United States District Court of Massachusetts in MDL 2768. See Specifically, Stryker Hip Implant MDL Selects Leadership Roles and Appoints Richard Schlueter of Childers Schlueter & Smith LLC to the Plaintiffs’ Steering Committee
For a free no obligation consultation about your Stryker Rejuvenate or ABGII hip implant recall, contact the hip implant recall lawyers at Childers, Schlueter & Smith, LLC. You can call us toll free, chat with our live team via the chat feature, or send us a confidential email to info@cssfirm.com
