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Stryker Hip Implant
Important Update: Stryker Recalls Stems of Hip Implants
The Michigan based medical device company Stryker in conjunction with its New Jersey based subsidiary Howmedica announced it was voluntarily recalling parts of its Rejuvenate and ABG II Hip Implants. The parts being recalled are the Stryker Rejuvenate Modular and ABGII modular hip stems. The recall was undertaken because of potential risks associated with its modular neck stems.
Stryker says the stems have the potential for “fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.”
The Stryker implant, like some of those manufactured by DePuy and Zimmer, can generate metal debris or tiny particles of cobalt and chromium that comprise the implant. When the debris sloughs off into surrounding tissues or the bloodstream, it irritates the tissues and can lead to swelling and pain. Sometimes the tissue around the implant can react to these metal ions resulting in both tissue loss called tissue necrosis and cyst formation called pseudotumor or pseudocapsule formation. Once a patient starts to loose tissue and/or has an onset pseudotumor, that process does not resolve itself but only gets worse with time. Unfortunately, there are also serious systemic health related affects including compromise or involvement of the liver, kidney, eye-sight, hearing, heart related compromise and cancer. It is noteworthy, however, that unlike the DePuy ASR related metallosis process, which primarily involves bearing surface wear from the interface of the metal ball and inner part of the monoblock shell or cup, with the Stryker Rejuvinate and ABG II, the metallosis process comes from fretting and/or corrosion at the junction of the ball and stem called the trunion, taper neck junction or simply the neck. Unfortunately, for Stryker patients, it is thought now that the size of the particulate sloughing off the necks in the Stryker scenario is smaller or more nano-particulate which may be more insidious and toxic to patients than larger metal particles. This complicates matters when evaluating patients’ blood serum levels for cobalt and chromium. That is, it is thought by prominent members in the medical community that i.e. 5 parts per billion of cobalt or chromium from bearing surface wear is cause for concern and increased monitoring but that this same level of metal ion release from taper neck wear seen with the Stryker Rejuvinate or ABG II is exponentially more toxic.
The implants Stryker uses are made by Howmedica Osteonics Corporation. Stryker said the reported rate for need for further surgery associated with fretting or corrosion in the modular neck junction is less than 1 percent.
The hip is a ball and socket joint. A hip implant is composed of two principal parts: the stem, which fits into the patient’s thigh bone and is topped by a ball and a cup, which fits into the patient’s hip socket and holds the ball of the stem.
If you or someone you love has needed revision surgery because of problems with your hip implant, the personal injury lawyers at the law firm of Aylstock, Witkin, Kreis & Overholtz can help you.
Stryker Rejuvenate Hip Litigation:
The Stryker Rejuvenate Hip Implant System was released in 2010 and is a modular hip system of femoral bodies and necks. Stryker claims this product “is designed with the potential to provide: (1) Enhanced Stability; (2) Proven Modularity and (3) Intraoperative Flexibility.” While the Stryker Rejuvenate Modular Hip System is not a metal-on-metal hip system there have been increasing reports of metal injuries at the location where the metal modular stem meets the metal neck of the device.
The Rejuvenate stem bodies are made of TMZF alloy, a proprietary Stryker material with a plasma sprayed coating of commercially pure (CP) titanium and PureFix HA. The modular necks are made of CoCr alloy.
The indications for use of total hip replacement prostheses include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and,
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Total hip replacement surgeries involve the replacement of both the head of the femur as well as the acetabulum (socket) of the pelvis. Stryker offers hip replacement products to address first time (primary) hip surgeries as well as revision systems.
Breaking News: Top National Products Liability Firm, Aylstock, Witkin, Kreis & Overholtz, based in Pensacola, Florida, files Petition with the Judicial Panel On Multi-District Litigation to have all federal cases involving the recalled artificial metal hip system: Stryker Rejuvenate and Stryker ABG II consolidated before one federal court. In April 2012, Stryker issued an Urgent Field Safety Notice to surgeons and hospitals, due to failures at the taper neck junction between the neck and stem, due to corrosion and fretting. Partner, Doug Kreis, a nationally recognized litigator and authority on metal hip related science, seeks a leadership appointment in furtherance of forcing Stryker to be accountable for the many thousands of consumers they have needlessly hurt. Mr. Kreis has filed a number of lawsuits against Stryker and its subsidiary Howmedica, stating: “The Stryker Rejuvinate and ABG II hip systems have an extremely high prevalence rate of premature failure causing the release toxic heavy metal ions into patients’ bodies resulting in horrific injury and potentially deadly consequences. We believe that nearly 100% of all patients with these Stryker systems will ultimately face premature failure and heavy metal exposure.” Mr. Kreis adds: “The most troubling aspect of this litigation is that, unlike most premature failures that result in surgeons removing various components but leaving in the femoral stem, the Stryker modular neck stem must be removed as well in this revision procedure leading to an extremely high risk to patients of complications post-removal.” Mr. Kreis has been representing clients with defective hip systems for nearly 15 years and has successfully resolved hundreds of clients’ claims relating to defective hip systems throughout the country. The firm is also pursuing other metal on metal and modular neck hip cases including: DePuy ASR; DePuy Pinnacle; Biomet M2a/Magnum; Wright Conserve; Stryker ABG II; Stryker Accolade TMZF; Zimmer Versys and Zimmer M/L.
Aylstock, Witkin, Kreis & Overholtz is investigating potential litigation involving the Stryker Rejuvenate Modular Primary Hip System, a comprehensive system of hip implants. In 2009 Stryker introduced the Rejuvenate Modular Primary Hip System. The Rejuvenate Modular Primary Hip System was touted as offering surgeons:
[U]nparalleled options for personalizing the implant to each patient’s anatomy. The Rejuvenate System is designed to optimize anatomic restoration by providing options that offer enhanced stability, proven modularity an intraoperative flexibility. The modular design enables the surgeon to independently manage stem size, leg length and offset to recreate the patient’s anatomy, restore biomechanics and, consequently, minimize the risk of dislocation.
The attorneys at Aylstock, Witkin, Kreis & Overholtz have been involved in orthopedic products liability litigation well over a decade. On December 8, 2000, Sulzer Orthopedics recalled its Inter-Op acetabular shell starting the first large-scale national orthopedic hip litigation. The firm’s attorneys helped injured patients achieve a successful resolution, starting the firm’s increase in prominence as leaders in the field of orthopedics product liability. Over the years, the firm has continued to assist patients with premature failures at a time when most of the firms throughout the country were unwilling or unable to represent individuals with unique hip related issues. In 2007, partner Doug Kreis began investigating adverse events relating to the Stryker Trident system and ultimately undertook the role as de-facto national lead counsel in the Stryker Trident ceramic on ceramic hip litigation. Mr. Kreis faced difficult express federal preemption defenses raised by the manufacturer, yet was successful in securing one of only a few favorable opinions, post-Riegel v. Medtronic, defeating express preemption in the case Hofts v. Howmedica Osteonics Corp., 597 F. Supp. 2d 830 (S.D. Ind. 2009) This proved to be a watershed moment in the Stryker Trident litigation. Along the way, Mr. Kreis has become one of the most knowledgeable attorneys in the country regarding orthopedic related law and science speaking at many mass tort seminars and symposiums throughout the country during which he addresses the current status of, and interplay between, science and law in the context of the epidemiology of medical devices; the potential modes of failure (general and specific causation); and the pathology, histology and presentation of related injuries – the intertwined relationship between science and the law. These speaking engagements include:
National Speaking Engagements:
- Defective Hips and Metallosis, Philadelphia, PA (October 5, 2012)
- Biomet Metal on Metal Failures – Hip Litigation Group Presentation, Chicago, IL (July 29, 2012)
- Metal on Metal Hip Science – Modes of Failure, Epidemiology & Damages, at Lexis/Nexis Studios, New York, NY (May 16, 2012) (nationally broadcast teleseminar)
- Biomet Hips, The Next Metallosis Epidemic – Hip Litigation Group Presentation, Scottsdale, AZ (February 11, 2012)
- DePuy Metal on Metal – Science on ASR/Pinnacle, Lead Litigation Group Seminar, New York, NY (July 13, 2011)
- DePuy Pinnacle Hips, Mechanisms of Failure/Defects, Hip Litigation Group Presentation, Las Vegas, NV (April 13, 2011)
- Depuy ASR Litigation Meets Science, Hip Litigation Group Presentation, Miami Beach, FL (February 7, 2011)
- Detailed Examination of the Defect and Resulting Injuries; Including Preservation of Evidence Issues, The J&J DePuy Hip Recall Litigation Conference, Durham, NC (November 17, 2010)
- Unique Causation and Damages with DePuy ASR, DePuy Hip Recall Litigation, Miami, FL (November 3, 2010)
Related Medical Literature:
Pseudotumor formation after hip arthroplasty is a rare complication that can occur with various head-liner articulation couples. Adverse local tissue reactions and pseudotumors have been shown to present as prosthetic infections or implant failures with a broad array of laboratory and imaging findings. We report a case of pseudotumor formation resulting from modular neckstem corrosion in a well-fixed ceramic-on-polyethylene total hip arthroplasty. The patient underwent successful revision surgery using an extended trochanteric osteotomy, long-stem revision femoral component, and headliner exchange. It is critical that surgeons are aware of the potential complications with increased component modularity and the possibility of adverse local tissue reactions resulting from fretting and crevice corrosion at modular junctions
Corrosion at the head-neck taper as a cause for adverse local tissue reactions after total hip arthroplasty. J Bone Joint Surg Am. 2012 Sep 19;94(18):1655-61. Cooper HJ, Della Valle CJ, Berger RA, Tetreault M, Paprosky WG, Sporer SM, Jacobs JJ.
BACKGROUND:Corrosion at the modular head-neck junction of the femoral component in total hip arthroplasty has been identified as a potential concern, although symptomatic adverse local tissue reactions secondary to corrosion have rarely been described.
METHODS: We retrospectively reviewed the records of ten patients with a metal-on-polyethylene total hip prosthesis, from three different manufacturers, who underwent revision surgery for corrosion at the modular head-neck junction.
RESULTS: All patients presented with pain or swelling around the hip, and two patients presented with recurrent instability. Serum cobalt levels were elevated prior to the revision arthroplasty and were typically more elevated than were serum chromium levels. Surgical findings included large soft-tissue masses and surrounding tissue damage with visible corrosion at the femoral head-neck junction; the two patients who presented with instability had severe damage to the hip abductor musculature. Pathology specimens consistently demonstrated areas of tissue necrosis. The patients were treated with debridement and a femoral head and liner exchange, with use of a ceramic femoral head with a titanium sleeve in eight cases. The mean Harris hip score improved from 58.1 points preoperatively to 89.7 points at a mean of 13.0 months after the revision surgery (p=0.01). Repeat serum cobalt levels, measured in six patients at a mean of 8.0 months following revision, decreased to a mean of 1.61 ng/mL, and chromium levels were similar to prerevision levels. One patient with moderate hip abductor muscle necrosis developed recurrent instability after revision and required a second revision arthroplasty.
CONCLUSIONS: Adverse local tissue reactions can occur in patients with a metal-on-polyethylene bearing secondary to corrosion at the modular femoral head-neck taper, and their presentation is similar to the adverse local tissue reactions seen in patients with a metal-on-metal bearing. Elevated serum metal levels, particularly a differential elevation of serum cobalt levels with respect to chromium levels, can be helpful in establishing this diagnosis.
The use of modular components in total hip arthroplasty has increased in popularity. The advantages of modularity in hip arthroplasty include improved visualization during acetabular revision and restoration of proper hip biomechanics. Disadvantages include disassociation of components, failure at modular junctions, corrosion, and the generation of metal ions and debris. We present 2 cases that demonstrate the potential for modular neck fracture, requiring subsequent revision of well-fixed components.
Metal debris should not be generated in a well-fixed, well-functioning metal-on-polyethylene total hip arthroplasty. However, surgeons sometimes encounter periprosthetic metallosis during revision hip surgery. Insert wear, fracture, or dislodgment in modular components may lead to articulation of the prosthetic head with the metallic shell and subsequent metallosis. Metallosis may occur with loose acetabular components as a consequence of fretting of the screws and shell screw holes or shedding of the ingrowth surface of the component. The femoral component can also be a source of metallosis: Wear of a titanium femoral head, loosening of rough surface finish from the femoral stem, and stem fracture all may result in metallic particles being deposited in periarticular tissues. Specific clinical and radiographic findings can help in differentiating these forms of failure and in planning surgery. When metallic debris-induced bone loss is recognized early, surgical intervention may limit its progression
Trident® Ceramic Acetabular System Class Action Lawsuit
On May 18, 2007, the firm of Aylstock, Witkin, Kreis & Overholtz filed a nationwide class action lawsuit seeking relief in the form of economic loss and cost associated with medical monitoring on behalf of all consumers who have had a Trident® Ceramic Acetabular System implanted from which an audible noise during motion, such as a squeak, occurs. The class action filed does not seek compensation for pain and suffering by definition, however, such claims are being evaluated individually.
New Jersey manufacturer Howmedica Osteonics Corporation developed, manufactured, marketed and sold the hip implant sold under the name Stryker Trident® Ceramic Acetabular System since September of 1999, distributing the same within the European Union countries, Australia and Canada. The Trident System contains a ceramic-on-ceramic acetabular bearing couple, indicated for patients requiring primary total hip arthroplasty or replacement due to painful disabling joint disease of the hip resulting from non-inflammatory degenerative arthritis. However, many reports of squeaking, screeching, popping, grinding and other noises have come out reaching a level of concern that has prompted researchers in both the United States and Europe to take action.
The FDA has issued a warning to Stryker Howmedica Osteonics Corp for their devices’ failure to conform with the Current Good Manufacturing Practice requirements in the Code of Federal Regulations. A copy of the warning is available here:
On November 3, 2006, at the 16th annual The American Association of Hip and Knee Surgeons (AAHKS) fall meeting, several surgeons presented their findings emanating from recent research they performed into the squeaking phenomenon. The results of these studies indicate that there was no correlation between cup position and squeaking, nor between anteversion and squeaking, thereby ruling-out physician error. Rather, they believe that impingement is a potential cause of the undesirable complication.
On December 1, 2006, Italian surgeons from Bologna (seat of the first European University since 12th Century) performed a study for the purpose of establishing guidelines for early recognition of clinical signs of ceramic liner fractures based on a twelve-year experience with modern ceramic prostheses. Aldo Toni, et al.: Early diagnosis of ceramic liner fracture. Guidelines based on a twelve-year clinical experience. J Bone Joint Surg -Am 2006; 88-A. Supplement 4: 55 – 63. The study revealed that squeaks from ceramic total hips were likely to be a precursor to hip failure. The study advised that early diagnosis of a ceramic liner fracture is desirable to avoid a wide spread of ceramic particles in the periarticular space. However, it advised further that a complication exists in choosing revision surgery after ceramic-on-ceramic failure where ceramic fragments have spread into the periarticular space given the abrasive character of the surrounding tissue and possibility of leading to early failure of the revision procedure. The Italian study concludes that poor construction of the cup component enhanced the risk of impingement and the liner fractures.
On January 22, 2008, Stryker Corp issued a recall for certain hip surgery products that the company claims did not meet internal specifications. The recalled products include the Trident PSL and Hemispherical Acetabular Cups, both of which were manufactured in Stryker’s facility based in Cork, Ireland. The internal recall represents the latest in bad press for a company that has been in the news throughout the last few years for failure to meet the Current Good Manufacturing Practice Requirements enforced by the FDA and for defects affecting certain Stryker products.
If you are a loved one has had defective hip replacement problems, please call the defective medical device attorneys of AWKO Law today at 1-(844) 794-7402 today, or contact us online.