MAJOR ALERT CONCERNING ALL

Stryker Hip Implant Recipients with Large Femoral Heads

Important Information for all individuals with Stryker Hip Implants

If you or a loved one was implanted with a Stryker Hip Implant that has a Large Femoral Head Component, please take note: Recent worldwide developments have resulted in the possible voluntary recall of specific hip implant femoral heads by Stryker Corporation in the United States. Specifically, the safety of certain catalog numbers of Stryker’s LFIT™ Anatomic CoCr V40™ Femoral Heads has been called into question. Many Stryker Hip Implant Recipients are asking the following questions:

 

What recent international events may have prompted Stryker Corporation to reassess the safety of some of its LFIT™ Anatomic CoCr V40™ Femoral Heads?

Two international events have raised questions about the safety of some of Stryker’s large femoral heads: 1) A mandatory recall of certain catalog numbers of Stryker’s LFIT™ Anatomic CoCr V40™ Femoral Heads was initiated in Canada; and 2) A Hazard Alert was issued by the Australian government regarding specific catalog numbers of Stryker’s LFIT™ Anatomic CoCr V40™ Femoral Heads.

 

On August 24, 2016, the Canadian Government initiated a mandatory recall of the aforementioned Stryker LFIT™ Anatomic CoCr V40™ Femoral Heads. Similarly, the Australian Registry issued a Hazard Alert regarding these Stryker Femoral Heads on September 27, 2016. Both the Canadian Government and Australian Therapeutic Goods Administration (TGA) indicated that these large femoral heads made by Stryker were linked to a higher-than expected incidence of failure of the Stryker hip implant taper locks at the Stryker Femoral Head-Neck Junction. It is important to note that these specific metal hip components have NOT yet been a part of any mandatory recall by the Food and Drug Administration (FDA) in the United States.

 

What are the potential issues, problems, and dangers associated with the use of large femoral heads in hip implants?

According to a journal article by the National Center for Biotechnology Information (NCBI), total hip arthroplasty is considered to be “one of the most successful orthopedic interventions of its generation.” Despite this “success”, the industry as a whole has taken a beating over the past few years due to the recalls of some hip implants, and problems with other hip implants.

 

Starting around 2006, there was a trend in the orthopedic community towards the use of larger femoral heads as a means of improving stability and free range of motion. There are, however, disadvantages to these larger femoral heads, including: more wear in metal on polyethylene bearings; elevated levels of metal ions; adverse local tissue reactions, and ALVAL (aseptic lymphocytic vasculitis-associated lesions).

 

These issues are more likely to occur in hip implants with larger femoral heads, and additional large femoral head problems continue to surface. Recently, a BioMed Research International article discussed head-neck taper corrosion in hip arthroplasty. While modularity at the head-neck junction became popular in the 1980’s, instances of taper corrosion were not reported until the early 90’s. In more recent years, the contributions of fretting and corrosion at the taper junction of hip implants are increasingly being recognized, and are becoming a cause for concern.

 

In studies that have examined the efficacy of femoral head size and stem pairings, there have been some notable observations pertaining to large femoral heads. One study in particular looked at CoCr alloy head and stem pairings that featured 12/14 mm tapers with metal-on-polyethylene articulations. The study found that a significant increase in taper fretting and taper corrosion was seen in the 36mm femoral heads as compared to the 28mm femoral heads. The type of corrosion identified was referred to as Mechanically Assisted Crevice Corrosion (MACC).

 

This mechanically-assisted crevice corrosion was also seen in a separate retrieval study which looked at 90 modular implants. In that study, taper fretting and taper corrosion damages varied, related to the type of articulation and the femoral head size. Articulation-related corrosion appears to be more likely in large femoral heads which are 36mm and greater and that are paired with a cross-link polyethylene liner, or no liner at all. Taper offset in smaller tapers, and head angles which are less than the neck angle may also contribute to taper fretting and taper corrosion.

 

When there are large amounts of corrosion in a hip implant device, the taper may separate from the bone (disassociation), or the femoral head and neck interface may wear down or degrade (trunnionosis). Other potential dangers include the deposition of metallic debris into surrounding tissue (metallosis), the development of growths around the implant (pseudotumors), and the death of nearby tissue (tissue necrosis). Broken bones, dislocation, and even total hip failure can also occur, and sometimes require femoral head hip implant revision surgery.

 

What specific issues, problems, and dangers have been linked to Stryker’s LFIT™ Anatomic CoCr V40™ Femoral Heads?

Both the Canadian Government Recall and the Australian TGA Hazard Alert regarding certain Stryker LFIT™ Anatomic CoCr V40™ Femoral Heads were based on higher than expected incidences of failure of the Stryker taper locks at the Stryker femoral head-neck junction. There may however be some more specific reasons as to why this particular Stryker Femoral Head is having problems:

 

What is Mechanically Assisted Crevice Corrosion?

Mechanically Assisted Crevice Corrosion or Fretting-initiated Crevice Corrosion is a type of “run-away” corrosion where fretting is no longer required for the corrosion to continue. To explain this more easily, “fretting” is simply the wear that occurs between two opposing surfaces, and “corrosion” is the gradual deterioration of a metal by a chemical and/or electrochemical reaction with its environment. So, whenever a hip implant component incurs wear or fretting, it exposes more of its surface area to the potentially corrosive environment of the surrounding body fluids. Play or toggle at the bore-taper junction (small taper with offset design and head angles less than neck angles) can contribute to movement based wear, and subsequently corrosion. If this movement results in enough wear/fretting/crevice formation, then corrosion may reach a level where further wear is no longer required for it to continue – and this is known as mechanically assisted crevice corrosion.

 

What is Galvanic Corrosion?

Galvanic Corrosion is an electrochemical process by which one metal immersed in the presence of a dissimilar metal deteriorates at an accelerated rate when the two metals are placed in electrical contact. One metal (the cathode, or positively charged metal) is actually protected while the other metal (the anode, or negatively charged metal) is corroded, as electrons basically flow from the “anode” metal to the “cathode” metal. When galvanic corrosion occurs in hip implant components, it is usually because the femoral stem and femoral head of the hip implant are made of two different metals. With the two metals immersed in body fluids, they are essentially placed in electrical contact, and galvanic corrosion can ensue. Galvanic Corrosion is more likely to occur when mismatched metals are implemented, and the changes in local chemistry within the crevices disrupt the protective oxide layer on the taper. More specifically, titanium stems (Ti-6AI-4V) paired with cobalt and chromium (CoCr) femoral heads can trigger galvanic corrosion, with a higher level of material loss from the bore of the head than from the trunnion.

 

Is the Stryker LFIT™ Anatomic CoCr V40™ Femoral Head prone to Mechanically Assisted Crevice Corrosion and/or Galvanic Corrosion?

The catalog of Stryker LFIT™ Anatomic CoCr V40™ Femoral Heads that has recently come under fire is most closely associated with four Stryker femoral stems – The Stryker Accolade TMZF, The Stryker Accolade 2, The Stryker Meridian, and The Stryker Citation. It is possible that the high incidence of Stryker taper lock failures associated with Stryker’s LFIT™ Anatomic CoCr V40™ Femoral Heads may be attributable to Mechanically Assisted Crevice Corrosion due to the femoral head offsets as well as the size of the tapers. It is also possible that the Stryker Accolade TMZF stem may be particularly prone to causing Galvanic Corrosion due to the metallic dissimilarity between the Chromium-Cobalt V40 femoral head and the Titanium-Molybdenum-Zirconium-Ferrous coating on the stem.

 

What are the potential dangers associated with the Stryker LFIT™ Anatomic CoCr V40™ Femoral Head?

Stryker is believed to have issued a notice to Orthopedic Surgeons about the potential dangers of these Stryker LFIT™ Anatomic CoCr V40™ Femoral Heads, including: 1) Disassociation of the Femoral Head from the Hip Stem; 2) Fractured Hip Stem Trunnion; Excessive Metallic Debris; 3) Insufficient Range of Motion (ROM); 4) Insufficient Soft Tissue Tension; Noise; 5) Loss of Implant: Bone Fixation Strength; 6) Excessive Wear Debris (Polymeric); and/or 7) Implant Construct with a Shortened Neck Length; These aforementioned potential dangers of the Stryker LFIT™ Anatomic CoCr V40™ Femoral Heads discussed above could potentially result in: 1) User Annoyance; 2) Loss of Mobility; 3) Pain Requiring Revision; 4) Inflammatory Response; 5) Adverse Local Tissue Reaction; 6) Dislocation; 7) Joint Instability; 8) Revision to Alleviate Hazardous Situation; 9) Pain Associated with Implant Loosening; 10) Periprosthetic Fracture; and/or 11) Leg Length Discrepancy;

 

Has there been a Stryker LFIT Anatomic CoCr V40 Femoral Head voluntary recall?

Many Orthopedists believe Stryker may be very close to announcing a voluntary recall of the LFIT Anatomic CoCr V40 Femoral Heads, which would come on the heels of higher than expected complaints related to the taper lock feature on certain catalog numbers of these Stryker Femoral Heads. So far, there has been no mandatory recall of the aforementioned large femoral heads by the United States Food and Drug Administration (FDA) to Stryker. Patients implanted with these Stryker femoral heads may have suffered Stryker femoral head hip implant failure, Stryker femoral head hip implant disassociation, Stryker femoral head trunnionosis and Stryker femoral head pseudotumors. Should Stryker Corporation officially declare a recall of these potentially dangerous femoral heads, and you have one of these femoral heads implanted in your body, you may want to consider contacting a Stryker femoral head recall lawyer to determine if you may be entitled to compensation for any Stryker femoral head recall injuries.

 

What Stryker hip implant models are most commonly associated with the Stryker’s LFIT™ Anatomic CoCr V40™ Femoral Heads in question?

The Stryker LFIT™ Anatomic CoCr V40™ Femoral Head has been most closely associated with use in conjunction with the Stryker Accolade TMZF (Titanium-Molybdenum-Zirconium-Ferrous), Stryker Accolade 2, Stryker Citation, and Stryker Meridian Hip Implant Stems. It is important to note that NONE of these Hip Implant Stems have been recalled. Only specific catalog numbers of Stryker’s LFIT™ Anatomic CoCr V40™ Femoral Head have been part of a mandatory recall in Canada, and MAY BE part of a possible voluntary recall in the United States by Stryker Corporation.

 

What are the specific catalog numbers of Stryker’s LFIT™ Anatomic CoCr V40™ Femoral Heads that may have been recalled?

 

CATALOG NO.            HEAD DIAMETER (MM)            OFFSET (MM)

6260-9-236                            36mm                               +5mm

6260-9-240                            40mm                               +4mm

6260-9-244                            44mm                               +4mm

6260-9-340                            40mm                               +8mm

6260-9-440                            40mm                               +12mm

6260-9-344                            44mm                               +8mm

6260-9-444                            44mm                               +12mm

 

Do other hip implant models / femoral heads pose the same risk as the Stryker’s LFIT™ Anatomic CoCr V40™ Femoral Heads?

Between the years of 2006 and 2012, it is estimated that as many as 225,000 hip implants with large femoral heads were implanted into patients. It is speculated that up to twenty different hip implant models from six different manufacturers (DePuy, Wright Medical, Smith & Nephew, Stryker, Zimmer and Biomet) may also employ the use of large femoral heads.

 

Now, while the use of femoral heads 32mm or larger has resulted in a nearly 50 percent reduction of hip dislocation rates, those larger femoral heads can also create higher levels of stress at the femoral head-neck junction. These stress levels are caused by the “play” between the bore and the taper which can result in femoral head fretting and corrosion, also known as trunnionosis. Also known as mechanically assisted crevice corrosion (MACC), this type of fretting and corrosion can lead to a whole host of additional problems.

 

Currently, while only the safety of Stryker LFIT™ Anatomic CoCr V40™ Femoral Head has been called into question, it is possible that other femoral heads and/or hip implant models may also be identified as problematic in the future, but this remains to be seen.

 

How do I find out if I have a recalled hip implant, a recalled hip implant component, or a potentially recalled Stryker LFIT™ Anatomic CoCr V40™ Femoral Head?

If you or a loved one is a hip implant recipient who believes you may have been implanted with a recalled hip, recalled hip implant component or one of the potentially recalled Stryker LFIT™ Anatomic CoCr V40™ Femoral Heads, it could be beneficial to contact the Stryker LFIT V40 Femoral Head Hip Recall Lawyers at Sullo & Sullo, LLP. Our Stryker Femoral Head Lawyers can acquire and analyze your medical records to: 1) determine if you were implanted with a dangerous or defective device, and 2) if you have a potential Stryker LFIT V40 Femoral Head Lawsuit, or another possible hip implant claim.

 

PRIOR STRYKER HIP ISSUES...THE STRYKER REJUVENATE AND ABGII HIP IMPLANT RECALL

The Stryker Rejuvenate and Stryker ABGII Hip Implants were recalled in July of 2012. If you were implanted with a Stryker Rejuvenate or Stryker ABGII Hip Implant, your time to file a claim is running out. The Stryker Hip Lawyers at Sullo & Sullo, LLP are currently evaluating potential lawsuits on behalf of individuals implanted with Stryker Rejuvenate or Stryker ABGII Hip Implants.


July of 2012 saw the recall of two more metal-on-metal hip implants: the Stryker Rejuvenate and the Stryker ABGII. Both Stryker models were manufactured using a specific type of modular neck hip stem, and both have been found to cause significant risks of metallosis and metal poisoning in implant recipients. If you received a recalled Stryker implant it is important that you are aware of the specific statute of limitations for product liability claims. The statute of limitations in the state of Texas and in the majority of other states is two years, therefore speaking to a Stryker hip attorney soon is essential.

 

Some states have product liability statutes as short as one year or as long as six years. Based on the recall date of the Stryker Rejuvenate and ABGII, the statute of limitations for Texas consumers is July, 2014, with individuals in states with longer statutes possibly having more time in which to file a lawsuit against Stryker. Speaking to a knowledgeable Stryker hip lawyer is the best way to establish when the statute for your recalled Stryker hip implant runs as well as determining the best course of action for harm you suffered due to a defective Stryker hip implant.

 

About Stryker Corporation

Stryker Orthopedics was founded in 1941 by Dr. Homer Stryker; today the huge corporation produces a wide array of orthopedic and other medical specialties, netting over $8 billion in annual sales. Over 13% of those revenues are the direct result of Stryker’s hip implant line. Despite the recall and the pending lawsuits, Stryker stocks hit a new lifetime high on April 4th, with shares rising to $84.85. If you have suffered serious harm from a recalled Stryker hip implant, it is crucial that you speak to a Stryker hip attorney as soon as possible in order to be eligible for a settlement associated with your injuries.

 

The Problems Associated With the Stryker Rejuvenate and ABGII

Stryker officials’ notified hospitals and surgeons of potential risks associated with the ABGII and the Rejuvenate about two months before the actual recall via an Urgent Field Safety Notification. Many believe this was a public relations tactic meant to minimize the effect of the eventual recall. In the safety notification, healthcare personnel were told that the Rejuvenate and ABGII had a high risk of fretting and corrosion at the neck junction, leading to the release of cobalt and chromium ions into the body.

The Stryker design was considered exceptionally innovative at the time of its release, due to the use of a ceramic ball rather than a metal ball. Further, a wide variety of neck and stem components allowed surgeons to custom-fit the hip device to the individual patient, depending on the patient’s size, body type and level of activity. Despite these apparent improvements over the “typical” metal-on-metal hip implants, Stryker failed to address a neck design which fits into the stem via a Morse taper junction, creating undue mechanical stress during periods of activity. In the end, the design which was touted as offering patients longevity as well as safety failed dismally in the delivery of those claims.

Following the recall, while Stryker would not put an exact number on the failure rate of the ABGII and the Rejuvenate, that number was estimated to be anywhere from 40-60%. Stryker metallosis can occur when the cobalt and chromium ions burrow into the surrounding hip tissues, leading to severe inflammation, chronic pain, the deterioration of bone and tissue, the failure of the hip implant and the necessity of hip revision surgery. Cobalt and chromium ions which make their way into the bloodstream are responsible for a wide array of very serious health issues including the following:

• Gastrointestinal disorders

• Neurological disorders

• Cardiovascular problems, including heart attack and stroke

• Certain types of cancers

• Reproductive disorders

• Diminishment or total loss of hearing and vision

• Loss of memory • Vertigo • Depression, anxiety, irritability

• The development of pseudo-tumors

• Alterations in DNA

• Skin rashes

• Changes in the ability to distinguish between sweet and salty foods

 

The FDA and the Stryker Recall

Both the ABGII and the Rejuvenate gained FDA approval through the controversial 510(k) process, which allows medical devices to be fast-tracked to approval, based on the devices “substantial similarity” to another device which is already on the market. Both recalled Stryker hip implants were approved based on their similarity to the Wright Profemur—a hip implant which has garnered hundreds of adverse event reports of its own, due to the risk of metallosis and metal poisoning. A qualified Stryker hip attorney can inform you further of the FDA’s role in the Stryker hip recall.

 

Current Stryker Litigation

Stryker is continuing in its efforts to settle Rejuvenate cases, and, in fact, eight of nine Bergen County, NJ cases were recently settled in court-ordered mediation, while four cases were settled for an undisclosed amount in late 2013. With more than 600 federal lawsuits currently consolidated under U.S. District Court Judge Donovan Frank in Minnesota, another 800 cases in New Jersey and 100 more across the United States, Stryker still has a long way to go. It is expected that as the statute of limitations close in, more lawsuits will be filed against Stryker Orthopedics. Reports state that Stryker has set aside over $1.2 billion to cover the losses associated with the Rejuvenate and ABGII recall. Speaking to an experienced Stryker hip attorney can ensure your lawsuit is filed in a timely manner and in a way that will result in a more positive outcome for your losses associated with a recalled Stryker hip implant.

 

Issues Associated With Stryker Revision Surgery

The removal of a Stryker Rejuvenate or ABGII is generally considered to be much more complex—as well as dangerous to the patient—than for other types of metal hip implants. The Rejuvenate in particular is constructed with an exceptionally long stem which is placed deeply into the femur at the time of implantation. When it becomes necessary to remove the stem, the surgeon must literally dig the stem component out of the femur which has grown around it. Due to the difficulty of the surgical procedure, the patient is likely to be on the operating table for up to five hours, exposing them to a higher risk of infection, excess bleeding and nerve damage. The mortality rate for patients undergoing a Rejuvenate or ABGII revision surgery is as high as 2.5% as compared to a 1% mortality rate for the original hip implant surgery. Your Stryker hip lawyer will thoroughly assess your case, including whether you have had or will need to have a revision surgery. Only a qualified Stryker hip attorney has the information you need to make an informed decision regarding your future.

 

How the Statute of Limitations May Affect Your Claim

The well-qualified Stryker hip attorneys of Sullo & Sullo, LLP can protect your claim based on the specific statutes of limitations involved in your Stryker product liability case. It is vitally important that you have a qualified Stryker hip lawyer by your side who will never miss a crucial deadline. Missing a critical statute of limitations deadline could negate your right to bring suit against Stryker for your injuries in the future, however only a qualified Sullo & Sullo Stryker hip attorney can determine when your statute began and whether there are potential exceptions based on the facts of your individual case. Whether you are currently experiencing problems with your recalled Stryker hip implant or not, it is important that you contact a Stryker hip lawyer; based on the statistics, there is a good chance you will suffer health issues related to your Rejuvenate or ABGII in the future. We don’t want you to miss the statute of limitations, thereby losing your right to recovery. Contact an experienced Sullo & Sullo Stryker hip attorney today to avoid such a possibility.

 

How an Experienced Stryker Hip Attorney Can Help You Pursue Damages

A Sullo & Sullo Stryker hip attorney can provide the information, legal advice and compassion you need and deserve for the injuries you suffered from a defective Stryker hip implant. Your Stryker hip lawyer will fight hard for compensation related to your injuries, including medical expenses, lost wages, pain and suffering, and, when warranted, punitive damages. The skilled Sullo & Sullo Stryker hip lawyers can provide a no-cost consultation in order to fully evaluate your specific Stryker hip implant claim. While your window of opportunity may be narrowing, only a well-qualified Stryker hip attorney can help you know for sure whether you are eligible to file a claim

 

For More Stryker Information Click Here...

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November 25, 2016 - After little more than two years on the market, Stryker issued a recall for the ABGII and the Rejuvenate, citing higher-than-normal Stryker hip failure rates as well as excessive fretting and corrosion. When fretting and corrosion occurs in those with metal hip implants, tiny metal ions can shear away from the device, causing symptoms of Stryker hip metallosis and/or Stryker hip metal toxicity.

 

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IMPORTANT AND URGENT INFORMATION for Injured Stryker Accolade, Stryker Meridian, and Stryker Citation Hip Implant Recipients: The Possible Voluntary Recall of Certain Stryker LFIT™ Anatomic CoCr V40™ Femoral Heads

Did Australian Health Officials Predict Issues with Stryker’s LFIT™ Anatomic CoCr V40™ Femoral Heads?

On September 27, 2016, The Australian Government Department of Health, through its Therapeutic Goods Administration (TGA), issued a ‘Hazard Alert’ to Australia’s citizens pertaining to Stryker’s LFIT™ Anatomic CoCr V40™ Femoral Heads. The TGA indicated that these hip implant components were linked to a higher-than-expected incidence of failure of the taper locks at the femoral head-neck junction. The TGA identified problems with four specific products, but also included three similar products in its hazard alert. While many Stryker LFIT™ Anatomic CoCr V40™ Femoral Head Lawyers view the TGA’s Hazard Alert with watchful eyes, it remains to be seen whether the TGA’s declaration was a precursor to the latest developments with the Stryker LFIT™ Anatomic CoCr V40™ Femoral Heads that are at issue.

 

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I Am a Stryker Hip Implant Recipient and Have Not Had a Revision—What are the Long-Term Risks of Having a Metal-on-Metal Hip?

September 27, 2016 - If you are one of the thousands of people who have a Stryker Rejuvenate or ABGII hip implant, and you have not yet undergone revision surgery, you may wonder about the long-term risks of having a recalled implant in your body. Patients with a Stryker hip device were likely dismayed to hear of the Stryker hip recall in July 2012. At the time of the recall, there was considerable talk of the Stryker hip failure rates, Stryker hip side effects and long-....

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