Stryker Hip Replacement Implant Lawsuit Hip Implant Recall Lawyer
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The Stryker Rejuvenate and ABG hip implant was recalled in July of 2012. These hips are failing at a high rate as a result of leaching of chromium and cobalt from the double modular neck of the implant. The joints in the modular neck components are corroding due to micro motion in the joints. The micro motion in the joint causes fretting and corrosion. This is a design defect in the product. Stryker had sent doctors promotional material stating that: “Laboratory testing demonstrates the compatibility of these materials without concern for fretting and corrosion.” So doctors had no reason to suspect that these hip implants were bad
This is why we think that Stryker will be held legally liable in the lawsuits that we are bringing against Stryker.
Patients with the Rejuvenate and ABG II hip implant are suffering from adverse reactions to the metal contamination that frequently require revision of the hip. These adverse reactions include inflammation, pain, limitation of motion, fluid in the hip compartment, damage to tissue in the hip compartment and damage to the bone.
The long term effect of this metal toxicity on the body is not well understood by doctors at this point. However, long term exposure to metal ions may have systemic effects on the nervous system or other organs in the body.
Stryker which is a division of Howmedica has contracted with an insurance adjusting firm called Broadspire to pay for out of pocket expenses not covered by insurance for Rejuvenate ABG II patients who need to pay for blood testing for metal levels or surgeries to replace the Rejuvenate ABG II hip implants. Broadspire is the same company that is paying out of pocket expenses for the DePuy ASR metal hip implant that was recalled in August 2010.
Initially, at the time of recall Stryker was not recommending that all Rejuvenate ABG II patients get regular blood testing for cobalt chromium levels. Recently, Stryker has changed its recommendations to include regular chromium cobalt blood testing every six months or once a year.
About twenty thousand Stryker Rejuvenate ABG II hips were implanted since 2009 when then the product was put on the market. The revision or reoperation rate is rapidly rising and it is possible that most patients will require replacement surgery.
Our office is representing Rejuvenate ABG II patients in lawsuits against Stryker and we are assisting patients in obtaining reimbursement for out of pocket costs and blood testing through the program with Broadspire. We expect that these lawsuits will be successful based upon the unreasonably high failure rate of these implants and the misrepresentation by Stryker that the hips would not be subject to fretting and corrosion.
The Stryker Rejuvenate Hip Recall for metal toxicity was a surprise to many patients and doctors because it is not a metal on metal hip. In fact, many patients selected this hip to avoid the metallosis problem that has been in the news for the last two years since the DePuy ASR metal on metal recall in August of 2010.
The Stryker Rejuvenate hip is made with a ceramic ball and a polyethylene liner in the acetabular cup. The recalled DePuy ASR and the recalled Smith & Nephew R3 hips both have a metal ball and a metal cup which is called a metal on metal articulation. The problem with the metal on metal hips is that the metal on metal interface generates metallic debris that is toxic to the tissues in the hip compartment causing fluid buildup, tissue damage, and failure of the implant.
The Stryker Rejuvenate was only briefly tested in the laboratory prior to widespread sale to the public. The Stryker Rejuvenate is made with a modular femoral neck. This is a different design than the traditional hip implant devices. The traditional hip implant devices had two parts, a femoral stem with a ball on it and then a cup that is placed in the acetabulum of the pelvis.
The Stryker Rejuvenate has four parts. It has a femoral stem, a metal neck, a ball, and an acetabular cup. The proposed advantage of the multipart or modular design is that the surgeon has a number of different metal neck parts of slightly different lengths and angles that he or she can choose to use during the surgery to try to obtain the best angle and length for the implant.
The problem with this design is that each time you have a metal joint between two different metal parts there is a risk of fretting from the movement in the metal joints and subsequent corrosion of the metal neck either at the joint with the femoral stem or the joint where the neck segment is inserted into the ball. The fretting and corrosion of the metal parts releases metal debris into the patient’s hip compartment where it will usually cause inflammation, fluid buildup and failure of the implant. That is why the Stryker Rejuvenate hips are failing and why they were recalled in August of 2012.
Stryker told doctors that the multi-part modular design of the Rejuvenate would provide better surgical results because they would be able to get better adjustment of angle and lengths during surgery. This representation sounds logical because it was sometimes difficult for surgeons to get the exact angles and leg lengths that they would prefer with the two part hip implants.
However, Stryker never properly tested this theory on people before its massive sales campaign to promote the Rejuvenate. Stryker tested the idea in a laboratory which is far different from observing how the devices function when implanted in people. Testing a product in a laboratory is also far different than conducting a proper scientific clinical study to develop scientific facts that can be reported.
A recent medical paper from the 2012 American Association of Orthopedic Surgeons meeting reported that “there is currently no clinical evidence that the use of modular necks is associated with improved function or reduced consequences of femoral-pelvic impingement.” This means that there is no scientific evidence that the theory of improved outcomes with these multipart or modular implants actually works in practice. It is just a theory and a sales pitch to sell more of the Stryker implants. Stryker never did clinical (that means on people) studies to see if the purported benefits of this product could justify the known risks of incorporating multiple metal junctions in a product designed to be implanted in the human body.
It has been well known in the hip implant industry that what is known as taper corrosion even in the traditional two part hips can be a source of metal debris that is a risk to patients. The taper is the stem from the femur to the ball. Scientific studies have been done that show that corrosion has been found in the DePuy ASR, and the Zimmer Durom Cup. These studies have also show that the larger diameter heads increase the risks of corrosion. In fact, this taper corrosion may contribute to the high metal ion levels in the DePuy ASR failures. So it is clear that there was significant scientific evidence of the risk of metal debris exposure and poisoning that Stryker was aware of when it promoted the modular neck design of the Rejuvenate.
It is clear that Stryker knew of scientific facts establishing the risk to patients of this metal exposure and the fact that there was a significant risk of exposure to this dangerous metal. It is also clear that Stryker had no scientific proof that the Rejuvenate design would result in better outcomes in patients. For those reasons it is likely that Stryker will liable to injured patients under product liability laws.
A product is considered defective in most states if the dangers of the product outweigh the benefits of the product. A manufacturer of a product such as the Rejuvenate can be legally liable for compensation to injured patients if the product is defective under this standard. A manufacturer of a product can also be liable if it is negligent in the design of a product. Negligence is the failure of a manufacturer to take reasonable care with regard to patient safety.
Consequently, I am confident that we will be successful in legal cases against Stryker for its marketing and sales of the Rejuvenate hip implant.
The Stryker Rejuvenate ABG II was first marketed in 2009. So, if your hip implant was before that date it could not be a Rejuvenate Hip. There was one hip implant on the market before 2009 with a modular neck. That implant is the Wright Profemur hip implant. That product has been on the market for over ten years.
The Stryker Rejuvenate was recalled in August 2012 so it is unlikely that a patient would receive this hip implant after that date.
If your received your hip between 2009 and August of 2012 it is possible that it could be a Stryker Rejuvenate. Your surgeon should be able to tell you whether you have this implant.
Our law firm also can obtain your medical records at no charge to you to determine whether you have one of these implants.
If you have one of these implants or think you have one of these implants you should get both legal and medical advice. There are legal statutes of limitations that mat bar your right to make a legal claim if you do not file your case with in specific time limits that are different in different states. So you should call us or another attorney experienced in medical device cases immediately to protect your rights.
You should also contact your orthopedic surgeon to ask for blood testing to see if you have elevated metal levels of cobalt or chromium in your blood. This is true even if you have no symptoms of pain or limitation of motion with your implant. Sometimes significant damages is done to the tissue in the hip before there are any symptoms of pain.
Stryker Hip Replacement Implant recall Corporation has announced a temporary recall of its Trident PSL and Trident Hemispherical Acetabular Cups used in hip replacement surgery. Stryker Hip Replacement Implant recall has known about problems with the hip devices since at least January 2005 when it began receiving complaints from patients who had received the hip replacement devices. The problem with the hip replacement components are two-fold involving manufacturing processes as well as issues regarding defective design.
After a six week FDA inspection, Stryker Hip Replacement Implant recall Corporation received an 11 page warning letter detailing numerous issues with the plant in Mahwah, New Jersey including evidence of bacterial contamination at the New Jersey plant. The contamination included “clusters” of Staphylococcus bacteria, the pathogen that causes staph infections.
Hip replacement patient complaints referred to poor fixation or loosening requiring revision surgeries, squeaking noises (from the ceramic on ceramic joints) requiring revision surgeries due to implant failures (fractures, pain, wear particles, and fragments), and improper seating resulting in bone fractures.
FDA’s Warning Letter made no distinction between cups manufactured in Mahwah, New Jersey and those made in Cork, Ireland. Because complaints regarding cups made in both locations are received in the Mahwah, New Jersey facility and the devices are the same regardless of manufacturing location, the FDA inspector reviewed all Trident cup complaints.
Douglas L. Ellsworth, District Director of FDA’s New Jersey District Office, indicated that the company’s attempts to investigate and identify the root causes of the cup problems and implement corrective actions were inadequate, violating the Federal Quality System Regulation.
Director Ellsworth also indicated that Stryker Hip Replacement Implant recall failed to comply with the Federal Corrections and Removals Regulation by failing to inform FDA of the removal from the market of Trident PLS Acetabular Cups due to the discovery of an operator’s failure to inspect product dimensional features resulting in the release of out-of-tolerance devices. Stryker Hip Replacement Implant recall ’s technical and medical assessment stated that the discrepancy could fully or partially prevent the taper on the ceramic sleeve from locking with the taper on the cup, allowing the ceramic liner to move freely within the cup. The motion between the two metal surfaces would cause metal wear debris particles which, over time, could lead to metalosis requiring revision surgery. Metallosis is defined as loosening, aseptic fibrosis or local necrosis of an implanted device as a result of metal corrosion and release of wear debris. The released debris particles provoke a foreign-body reaction that ultimately leads to osteolysis and prosthetic loosening.
Additionally, “if compressive forces are removed from the hip, the liner may be able to slide out of the shell and dislocate the patient’s hip,” requiring revision surgery. Also, a non-solidly locked insert poses the greatest risk since it would potentially lead to immediate removal and change of the shell or premature failure due to debris. Even if the locking head were only partially captured locking strength would be compromised resulting in disassociation requiring revision surgery.
Stryker Hip Replacement Implant recall ’s Inadequate Response
The November 2007 letter from the FDA was not the first warning issued to the medical device company. The November letter refers to Stryker Hip Replacement Implant recall ’s failure “to perform corrective and preventive actions in order to prevent the recurrence of nonconforming product or other quality problems.” The FDA complains in the letter that Stryker Hip Replacement Implant recall “has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence.”
In response to the Warning Letter, Stryker Hip Replacement Implant recall issued a press release on January 22, 2008, announcing the temporary and voluntary withdrawal from the market of Trident PLS and Hemispherical Acetabular Cups made in Cork, Ireland. The announcement indicated that product manufactured in Mahwah, New Jersey was not affected and that all Cups, regardless of place of manufacture, met all US and international performance standards for sterility and biocompatibility. Stryker Hip Replacement Implant recall explained that the withdrawn product simply deviated from internal specifications. The company added that “medical expert opinion of current and historical data concludes that there are no safety issues for patients who received these products. In fact, independent clinical evidence confirms that the performance of these cups compares very favorably with other high performing acetabular devices.”
On March 15, 2007, Tim Ulatowski, Director of FDA’s Office of Compliance for devices, issued a Warning Letter to Mr. Michael McGrath, General Manager/Vice President of Stryker Hip Replacement Implant recall Ireland, Ltd., based on a 2006 inspection of the Cork facility. The Warning referred to several packaging issues and bioburden problems with the Final Rinse Tank. Mr. Ulatowski acknowledged the anticipated completion date of February 28, 2007 of the firm's voluntary recall of all Hip Fracture Stems.
A more recent Stryker Hip Replacement Implant recall recall , this one involving 142 US-made Trident PSL Acetabular Shells and HA (hydroxyapatite) Solid Back Acetabular Shells – distributed in the US and Brazil -- was initiated August 30, 2007. The company explained that specific lots “may have a dimensional discrepancy. The deviation regarding the difference in wall thickness could increase the gap between the shell and liner on one side and while decreasing the gap between the shell and liner on the other side resulting in interference.”
Headquartered in Kalamazoo, Michigan, Stryker Hip Replacement Implant recall reported orthopedic implant sales of $3,570.7 million for the year 2007, representing an increase of 14.8% compared to 2006. The company’s total 2007 sales were $6,001 million. Founded in 1941 by Dr. Homer Stryker Hip Replacement Implant recall , today the medical technology company boasts a broad range of products in orthopedics and a significant presence in other medical specialties. Products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; and patient handling and emergency medical equipment.
A total hip replacement is a surgical procedure during which the diseased cartilage and bone of the hip joint is surgically replaced with artificial prostheses. The normal hip joint is a ball and socket joint. The socket is a "cup-shaped" bone of the pelvis called the acetabulum. The ball is the head of the thigh bone (femur). During surgery the diseased socket and ball are removed and replaced with a system that includes an acetabular shell or cup (socket) with a plastic or ceramic insert and metal or plastic ball affixed to a femoral stem.
Stryker Hip Replacement Implant recall has marketed the Trident Acetabular System since 1999. The system features a locking mechanism and several options, including cluster or solid-back shells, hydroxylapatite (HA) coating, alumina ceramic and two different polyethylene bearing surfaces, eccentric and constrained shell geometries, and Tritanium fixation.
Stryker Hip Replacement Implant recall has widely promoted its Trident Ceramic System, especially for younger, more active patients. Stryker Hip Replacement Implant recall proclaims that “laboratory and clinical data indicate that ceramic bearings may be the most significant advancement in total hip replacement wear performance, helping to reduce wear to near undetectable levels.”
The system includes the shell of cup that is implanted into the patient’s acetabulum (hip bone); a ceramic insert/titanium sleeve assembly which forms the socket; and a ceramic head or ball. The femoral stem is not shown.
The insert and head of the system are both made of alumina ceramic which, Stryker Hip Replacement Implant recall states, significantly lowers wear compared to conventional plastic-on-metal or metal-on-metal joint systems, at least “in the laboratory.”
A shrink-fit titanium sleeve encapsulates the ceramic liner which Stryker Hip Replacement Implant recall states increases the material strength of the ceramic insert compared to other ceramic inserts on the market.
However, there have been longstanding concerns that brittle ceramic material is associated with a higher fracture risk, a "squeak" phenomenon, and potentially a higher dislocation rate secondary to limited neck lengths and liner options. Stryker Hip Replacement Implant recall claims that a study involving 1635 patients have dispelled those concerns.
Yet, orthopedic surgeons in the UK reported in a 2007 issue of the Journal of Bone and Joint Surgery (British Volume) several instances of incomplete seating of the metal-backed alumina liner. A. J. Langdown and others reviewed 117 hips in 113 patients who had undergone primary total hip replacement using the Trident shell with a metal-backed alumina liner. “Of these, 19 (16.4%) were noted to have incomplete seating of the liner, as judged by plain anteroposterior and lateral radiographs. One case of complete liner dissociation necessitating early revision was not included in the prevalence figures. One mis-seated liner was revised in the early post-operative period and two that were initially incompletely seated were found on follow-up radiographs to have become correctly seated.” The surgeons went on to suggest that “there is the distinct possibility that the Trident shell deforms upon implantation, thereby preventing complete seating of the liner.”
A follow-on letter from M.K. Sayana, from Dublin’s Cappagh National ORthopaedic Hospitals asks: “Would not the surgical company recall the product if the incidence of incomplete seating is so high?”
If you or a loved one have been injured by a Stryker Hip Replacement Implant recall hip replacement, please contact us immediately. We are prepared to help you.
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Stryker Hip Replacement Implant recall filing reveals new investigation
MAHWAH, N.J., March 11 (UPI) -- A New Jersey subsidiary of Stryker Hip Replacement Implant recall Corp. is under investigation for paying bribes overseas, The Washington Times reported Tuesday.
Stryker Hip Replacement Implant recall Orthopedics Inc. of Mahwah, N.J., one of five companies implicated in a $230 million kickback scheme in which physicians were paid consulting fees to endorse or prescribe their products, is being examined by the U.S. Justice Department, the newspaper reported.
A recently completed New Jersey Attorney General's Office probe alleged the companies paid U.S. physicians lucrative fees for nominal services between 2002 and 2006.
Stryker Hip Replacement Implant recall Orthopedics cooperated with prosecutors and escaped a fine, but agreed to federal monitoring for 18 months. The other companies, Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc. and Smith & Nephew Inc. agreed to a $311 million settlement with the Justice Department and the U.S. Department of Health and Human Services.
The five companies command 95 percent of the world's market of hip and knee surgical implants.
According to the SEC filing, Stryker Hip Replacement Implant recall Orthopedics is under investigation for "possible violations of the Foreign Corrupt Practices Act," which covers bribes made overseas, the Times reported.
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