Stryker, one of the largest and most popularly used hip implant manufacturers, is facing some potentially major product liability legal problems surrounding one of their metal-on-metal hip replacement system. This isn’t the first time, however, that their metal hip implant systems have been pulled from the market for putting patients at risk. In 2012, they recalled two other hip systems—the Stryker Rejuvenate Hip and the Stryker ABG Hip. They quickly became inundated with lawsuits from former patients claiming that the Stryker hip they had implanted had caused serious complications (metal poisoning, dislocations, catastrophic failure, etc.) leading to injury and typically a revision surgery.
The Stryker Rejuvenate and Stryker ABG II brands were recalled because friction between the neck and stem, made of cobalt and chromium, release toxic metal ions into the surrounding tissue. This Stryker Hip Recall affects thousands of patients.
Stryker may be back in the hot seat. On August 29, 2016 they recalled issued an urgent warning to medical device implant orthopaedic surgeons that hip implant patients were experiencing extremely high failure rates of prosthetics containing their LFIT (Low Friction Ion Treatment) V40 femoral head. Stryker explained that “higher than expected complaints of taper lock failure” has been occurring which could lead to a complete disassociation of the femoral head from the hip stem, excessive metal debris in the hip joint and dangerous metal poisoning in hip replacement patients.
Stryker may now face negligence claims for failing to warn physicians and patients many years earlier when recalling their Rejuvenate and ABG hip implants, which included the LFIT V40. when Many patients have already been injured some are experiencing catastrophic hip implant failure.
Artificial hip implant systems consist of several parts that work together to create the “hip system”. These parts generally include a:
The LFIT V40 is the femoral head component used in many of the Stryker hip implants and can be better understood as the part that replaces the “ball” at topmost part of the femur or upper thigh bone. The ball then fits inside the socket of the pelvis bone which makes hip joint rotation possible.
The Stryker LFIT V40 Femoral Heads are used with the following replacement hip implant systems used over the past 17 years:
Of course, the LFIT V40 Femoral Head was designed to make the replacement hip implant more advanced than their previous models and competitors’ hips. Stryker claimed, in fact, that this design would minimise the risk of dislocation and maximise hip range of motion and stability. They also explained that the “Low Friction Ion Treatment” technology would significantly reduced friction in the hip joint which would provide a longer lifespan for the prosthetic hip. Unfortunately, actual real life case studies proved the opposite: the LFIT technology was actually becoming part of the problem by increasing the metal on metal wear and tear leading to metallosis, tissue damage, pain, swelling, immobility, and catastrophic hip implant failure.
Recent medical research has revealed that there are serious issues and serious health concerns when it comes to the Stryker LFIT 40. Notably, one of the most serious and concerning incidences is where the femoral head actually disconnects from the femoral stem. This could mean the joint actually loosening and actually disconnecting from the upper thighbone. In other cases, research has found that corrosion can occur at the head-neck juncture of the implant. Seeing as the implant is made of cobalt and chromium, these metallic materials can wear out with time causing corrosion than poisons the surrounding tissues and cells, weakening the joint and could result to a catastrophic failure of the implant.
For those who have had a Stryker hip replacement procedure and are concerned about the LFIT V40 head causing the implant to fail, you should report any of the following symptoms to your physician immediately. If you find yourself experiencing these symptoms it may indicate the V40 femoral head is corroding, creating increased joint friction and may lead to serious injury.
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 a decent way to examine the bone and device placement but an MRI often provides more specific information. Without an MRI a patient may not recognise 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 if there is a sign of medical complications.
In a more precise manner, Symptoms of hip implant failure may include:
These symptoms may indicate that the Stryker LFIT V40 Femoral Head is failing and you may be at risk of the following severe injuries, which could require invasive revision surgery to correct:
The high incidence of patient complaints of symptoms and/or injuries related to the Stryker hip implants spurred recalls of the LFIT V40 worldwide:
On August 24, 2016: Health Canada recalled the Stryker LFIT CoCr V40 Femoral Head for the reason that Stryker had received a higher than expected number of complaints of failure of certain sizes of the LIFT V40 hip implant manufactured in the preceding years.
On August 29, 2016: Stryker published their “urgent medical device product field action notification” to orthopaedic surgeons and issues a voluntary recall of the LFIT V40
On September 27, 2016: Australian health officials received an urgent warning regarding the potential health hazard associated with certain Stryker hip implants.
If you have had a recent hip replacement surgery, are experiencing any health complications and believe that you have a Stryker Hip System that contains an LFIT V40 Femoral Head, you should see your doctor as soon as possible for an X-ray or MRI of the hip joint to determine the possible cause of these side effects before a severe injury occurs.
The U.S. Food and Drug Administration states on the Metal-on-Metal Hip Implants section of its website, “Metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.”
The Food and Drug Association advocates the following measures for any patient experiencing symptoms that suggest their implant is not functioning as it should:
that metal on metal patients should be extra-aware of their general health, as some medical literature suggests metal on metal hip implants can lead to systemic reactions elsewhere in the body.
Among these potential reactions are skin rash and hypersensitivity, cardiomyopathy, neurological changes, renal function impairment, depression or cognitive impairment, and thyroid dysfunction.
Furthermore, In the spring of 2010, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning about metalled metal hip replacements. In this alert the MHRA advised patients to get blood tests and imaging to ensure they didn’t have metal poisoning. Two years later, the MHRA issued a follow-up with guidelines on monitoring and caring for metal on metal hip patients.
In 2012, Health Canada issued an alert containing important safety information for metal on metal hip replacement surgeons and patients. This alert detailed that In recent years, there has been an increase in awareness of pain, implant loosening and significant soft tissue reactions thought to be the result of increased levels of metal (cobalt and chromium) ions in the surrounding joint tissue. Soft tissue reactions can range from fluid collection to more extensive necrotic and “pseudotumor” reactions and can necessitate device revision.
Health Canada also reported that “14.2% of revised metal on metal hip implants exhibited soft tissue reactions.”
Stryker Orthopaedics, the manufacturer of the failed prosthetic devices, advises hip replacement patients without current symptoms simply continue following the post-operative plan outlined by their surgeon. However, this advice has negative and traumatic long-term consequences, both physically and financially. Whether or not you have pain, swelling or other unexplained symptoms, immediately have your blood tested for cobalt and chromium. Patients with cobalt and chromium levels above 0.3 micrograms per litre (mg/l) or parts per billion (ppb) need to be monitored since these levels are abnormal. At this juncture, it is also imperative that patients contact a Stryker Rejuvenate attorney who helps protect their legal rights. The manufacturers must assume financial responsibility for their negligence which entitles patients to monetary compensation for their pain and suffering.
If you have a Stryker Rejuvenate or Stryker ABG II hip implant, get in touch with an attorney right away. Time is of the essence with the statutes of limitations for these cases. In most states, the Stryker Hip Recall deadline is 2 years but some states have statutes of limitations run in as little as 1 year.
Stryker Orthopaedics, the manufacturer of these modular hip implants, may pay billions of dollars in settlements and legal costs arising from hip replacement lawsuits. Injured hip replacement patients often qualify for compensation for costly revision surgeries. In addition, patients with Stryker hip problems are eligible to receive monetary compensation for lost wages, medical bills, future treatment, and pain and suffering.
Manufacturers of products are generally held to a basic duty of exercising care to prevent foreseeable injuries from the reasonable use of their products. In the case of medical devices, manufacturers owe a duty to patients to produce and sell products that are safe and effective.
The Stryker lawsuits charge that Stryker violated these basic duties. Stryker did not conduct any clinical testing on the safety and effectiveness of the Rejuvenate and ABG II hip systems before selling the devices. Both the Rejuvenate and ABG II devices are defective, the lawsuits allege, because the modular neck is prone to fretting, degradation, and fracture. Further, the lawsuits allege that Stryker knew or should have known that the Rejuvenate and AGB II hip systems were not safe for patients, yet Stryker continued to market and sell these products. The lawsuits filed by the Stryker hip patients seek compensation for their pain and suffering.
Patients who were implanted with the Stryker LFIT V4o hip implant system then suffered serious side effects or injuries may be eligible to bring lawsuits. Patients may be unaware of what components were used in their hip replacements and in such a case, they should seek consultations to help them determine what components were used, and whether they have a feasible case against Stryker.
The federally filed injury claims regarding the August 29, 2016 recall of Stryker Orthopaedics’ LFIT Anatomic CoCr V40 (Stryker LFIT V40) Femoral Heads have been centralised by the U.S. Judicial Panel on Multi district Litigation (JPML).
The JPML found that the 33 lawsuits currently filed in seventeen federal courts across the country share common issues of fact, and to promote the just and efficient handling of the litigation, the pending actions will be consolidated before Judge Indira Talwani of the U.S. District Court of Massachusetts. While the JPML stated that there will undoubtedly be some individualised factual issues in each lawsuit, at this early stage of the litigation, these issues do not negate the judicial efficiencies gained at this point in time by centralisation.
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.
If you had a Hip replacement and are suffering from pain , you may be entitled to a settlement. Cases are settling now, it is important that you act immediately. Contact Schmidt National Law Group today for a free case evaluation by calling 1-800-631-5656 or use the form on the bottom of this article.
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Stryker Hip lawsuit claims and settlements page updated on August 24, 2017
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