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Why Have the Stryker Rejuvenate and ABG II Modular Hip Neck Systems Been Recalled?

Why have the Stryker Rejuvenate and ABG II Modular Hip Neck systems been recalled?Rosenfeld Injury Lawyers LLC represents people with post-surgery injuries caused by defective medical devices including replacement hip and knee implant procedures and other types of professional negligence. Our law firm has extensive experience in resolving cases for our clients who have required revision surgery after receiving the malfunctioning implant that was voluntarily recalled by the device manufacturer or forcibly recalled by the Food and Drug Administration.

Our attorneys are available to answer any legal question on how to receive the compensation you deserve if a malfunctioning medical device injured your loved one. Should you have additional questions, we invite you to contact our office for a free review of your legal rights.

Stryker Implant Injury Information

The defective hip implant injury attorneys at Rosenfeld Injury Lawyers LLC provided the facts posted below to assist families in making a better-informed decision list when seeking justice in taking legal action to obtain the compensation they deserve for their injuries.

Since the medical industry first made hip implant surgery possible, hundreds of thousands of individuals have undergone the procedure in America every year. The operation is considered an ordinary surgical procedure. Many patients agree to the hip implant procedure to alleviate pain and other symptoms associated with rheumatoid arthritis, degenerative joints, femur neck fractures, avascular necrosis or functional deformity of the hip.

Nearly all the hip joint replacement procedures are performed on individuals 45 years and older. Recent medical innovations have reduced the patient's recovery time through minimally invasive procedures. However, the defective design and manufacturing processes of artificial hip replacement devices still pose substantial dangers to individuals in the weeks, months and years after their surgery.

As early as 2012, the Food and Drug Administration (FDA) issued recalls on hip devices claiming that the metal-on-metal hip implant systems manufactured by Stryker were causing significant problems. Thousands of patients had complained of severe injuries, ongoing pain, and the need to undergo extensive revision surgery after receiving the implant. Since that time, the recalls have continued to spark a massive rush to county courthouses to participate in class action lawsuits and mass tort financial claims against the Stryker Corporation, the manufacturer of the numerous defective hip implant models.

Currently Recalled Stryker Implant Devices

The FDA recall on Stryker modular hip systems continues because many of their devices have been proven to cause severe side effects in numerous implanted models including the:

  • Rejuvenate
  • ABG II
  • Meridian TMZF Stem
  • Citation TMZF Stem
  • Accolade TMZF
  • LFIT Anatomic CoCr Femoral Metal Head

The FDA investigators identified specific problems and side effects associated with a dozen plus hip replacement products. Many models generated a higher than expected failure rate where the patient experienced one or more side effects that include:

  • Hip replacement failure
  • Difficulty maintaining balance
  • Difficulty standing or walking
  • Hip stem breakage
  • Dislocated implants
  • Metal ion generation
  • Metallosis (metal poisoning)
  • Neck joint corrosion leading to metal debris release
  • Severe pain
  • Implant site information
  • Joint noise including squeaking, popping, snapping and clicking

Defective Designs

The Stryker orthopedics device manufacturing process of metal-on-metal hip implants is known to produce severe problems in some individuals. Many patients injured by their devices underwent hip joint replacement surgery to replace damaged cartilage or bone with a prosthetic joint. While many manufacturers develop joint replacement devices constructed of polyethylene and ceramic, the Stryker Corporation focuses primarily on metal-on-metal hip replacement devices including a partial hip resurfacing device and a total hip replacement unit.

The total hip joint devices replace both the patient's natural socket (acetabulum) and ball (femoral head) with an artificial device in the patient's hip joint. The resurfacing metal-on-metal device replaces only the natural socket and resurfaces the femoral head. Stryker produces products that lack many of the traditional metal features of metal-on-metal devices to minimize problems. Even so, some patients have experienced significant adverse local tissue reactions (ALTRs) that resulted in severe injuries and the need for revision surgery.

Upon pressure from the Food and Drug Administration (FDA), Stryker issued a series of “Urgent Field Safety Notices” that were sent out to surgeons and physicians detailing the potentially dangerous risks of using their devices. The warnings identified the risks to patients including developing:

  • The release of metallic debris
  • Generating metal ions
  • Metallosis (metal poisoning)

In addition to issuing the Urgent Field Safety Notices, Stryker also took the advice of the Canadian Health Authority in August 2012 to urge surgeons and doctors to contact their patients and notify them of the potential risks, and voluntary recalls of their products. The doctors were to encourage their patients to contact the Stryker Corporation.

Other known problems that create toxic metal corrosion and severe adverse events include:

  • Necrosis where the bone and tissue dies from metallosis toxicity.

  • Osteolysis caused by metal toxicity where necrotic bone tissue dissolves.

  • Pseudotumor Development involving the formation of a false tumor surrounding the inflamed joint.

  • Systemic Metallosis where the metal poisoning enters the bloodstream and causes widespread toxic inflammation.

  • Bone Fractures caused by weakening bone tissue surrounding the affected joint.

  • The Need for Revision Surgery required to replace the severely inflamed or painful implant.

  • The Need for Reconstruction Surgical Procedures to restore damaged bone tissue that is causing pelvic or femur fractures

While all hip implants can produce severe side effects, the devices manufactured and distributed by Stryker have been shown to have elevated rates of unexpected corrosion, joint failure, metal ion generation, and the release of metallic particles. The Stryker models are known to cause immune system reactions, systemic inflammation and metal poisoning that leads to life-threatening infections, headaches, fatigue and skin rash.

Patients who undergo revision surgeries or reconstructive procedures can experience substantially more pain compared to their first replacement surgery. Also, the recovery time is significantly longer after the revision procedure. Some of the less severe side effects associated with Stryker revision surgery include:

  • Abdomen or groin implant area inflammation

  • Abdomen or groin implant area pain

  • Hip dislocation

  • Significant loss of muscle mass associated with pain, difficulty in moving, or immovable joints

  • A significant challenge in maintaining stability, walking or standing

A Faulty Design

The Stryker Corporation has long known of the associated side effects with their ABG II and Rejuvenate models caused by a faulty design. The device manufacturer designed the product with a mono-block neck and stem design to maximize stability and minimize the stress on the femur and pelvic bones.

The design involved manufacturing the device using chromium and cobalt and a neck stem coated in titanium. The designers thought the corrosion-resistant properties would minimize most problems in patients implanted with the implant after many years. However, metal-on-metal rubbing together can quickly cause health issues when the implant unit begins releasing metal debris and toxic metal ions into the surrounding tissue.

A Rush to the Medical Marketplace

Over a decade ago, Stryker received approval from the Food and Drug Administration on its joint replacement devices through an expedited process. The company filed for a 510(k) Premarket Notification Process approval, which is significantly less stringent than the typical medical device approval processes. The exemption from the more rigorous FDA approval allowed the company to get their devices quickly to the medical marketplace while avoiding expensive clinical testing.

Typically, the FDA requires clinical trials to understand the problems better before the product is available to the public. However, Stryker allowed patients to undergo surgical procedures using their defective product without the benefit of the company providing clinical trials results on the unit's safety and efficacy. Releasing the product to the medical community before identifying dangerous scenarios fails to provide an adequate safeguard against unexpected results and adverse reactions unsuspecting consumers developed nearly immediately.

A Patient's Legal Response

Many patients have filed lawsuits against the Stryker Corporation claiming that their Rejuvenate and ABG II hip replacement devices have caused significant problems including fretting and metal corrosion. Many of these victims have undergone revision surgeries to restore their hip in the hopes of alleviating many of the symptoms caused by the defective implant product.

To date, thousands of lawsuits have been filed in Federal (Minnesota MDL – multidistrict litigation) courts and through state judicial systems citing problems with the Stryker implant devices. Hundreds of lawsuits have already been filed and settled. However, many more lawsuits will likely be filed soon as more patients begin experiencing problems in the months and years after their initial replacement procedure. Currently, tens of thousands patients in America have undergone surgical procedures for a Stryker implant device.

These victims are filing lawsuits based on the defective design and faulty manufacturing processes of the Stryker hip implant products, especially the Rejuvenate and ABG II devices. Their attorneys have built their cases on the company's failure to warn the medical community and patients of the known severe side effects that arise out of metal-on-metal devices. These lawsuits have revealed the company's failure to adequately test their products in humans before offering the units in the medical marketplace for public use. Also, the attorneys working on behalf of the plaintiffs are providing evidence to show that the device directly caused severe, life-threatening adverse events.

Some victims have foregone multidistrict litigation and class action lawsuits and instead filed individual claims for monetary recovery directly against the Stryker Corporation to ensure they receive adequate compensation.

Ready to File Your Stryker Injury Lawsuit?

Any patient who has undergone a hip replacement surgical procedure and now suffers severe adverse events caused by metal toxicity or a device defect should consider filing a lawsuit. Typically, plaintiffs can receive compensation to improve the quality of their daily life and relieve their financial burden. Holding the device manufacturer financially accountable for their negligence in designing, manufacturing, marketing and selling a defective product could help others who might not be aware that there are legal remedies when a faulty implant causes their injuries, pain, and suffering.

If a faulty Stryker hip implant unit caused your loved one harm, their injuries might be the result of medical negligence or defective medical device. The product liability and medical malpractice attorneys at Rosenfeld Injury Lawyers LLC provide legal assistance to patients who have suffered injuries after undergoing surgical procedures. Our law firm has successfully prosecuted hundreds of medical device injury cases to ensure our clients are adequately compensated for their damages.

Contact our attorneys today to schedule a free, no-obligation case consultation to discuss the merits of your compensation claim. Our legal team accepts all personal injury case, wrongful death lawsuit, product liability suits and medical malpractice claim through contingency fee agreements. This arrangement postpones the payment of legal services until after we have successfully resolved your case through a jury trial or negotiated out of court settlement. Additionally, we provide every client pay “No Win/No-Fee” Guarantee, meaning if we are unable to secure financial compensation on your behalf, you owe us nothing. All information you share with our law office remains confidential.

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