Articles Posted in Replacement

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The Right Doctor for youRevision surgeries for patients who received Stryker Rejuvenate hip implants are much more complex and difficult than people believe them to be . For this reason, many surgeons and doctors are cautious about recommending or performing the procedures due to the significant risks associated with them.

Each patient’s age, existing medical conditions and the complications that they are experiencing due to the defective device are all considered, but doctors typically consider revision surgery to be a last resort measure— only to be performed if the patient is suffering severe complications or at an elevated risk of life threatening conditions.

The Dangers of Hip Revision Surgery

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When people die on the Operating TablePatients Dying During A Hip Revision Procedure

Every year, thousands of individuals suffering from limited mobility undergo hip replacement surgery to improve the quality of their life and eliminate pain in their hip. Unfortunately, not every hip replacement surgery is successful. Often times, significant issues arise where there is an immediate need for revision surgery. The existing device is replaced with a secondary implant after a lengthy and complex procedure. Unfortunately, some patients die during the hip revision surgery as a result of complications, or in the months or years that follow.

Usually, patients elect to have hip replacement surgery as a way to decrease their pain and increase mobility. The diseased or damaged bone and associated tissue is replaced with an artificial implant. The need for hip replacements has never been greater, as more Americans live longer than ever before with highly active lives. The recipient of the hip replacement device is often an individual who has endured sports injuries, or significant trauma to their hip joint.

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DVT and hip surgeryPostoperative deep vein thrombosis (DVT) can be a significant problem after a Stryker hip revision surgery, leading to lethal complications. Many times, DVT is challenging to diagnose because classic clinical symptoms and signs are not always present. If the doctor is not suspicious or curious of obvious lacking signs, the individual can develop significantly serious problems, which could lead to death.

In 2009, the Stryker orthopedic medical device company began marketing its Rejuvenate and ABG II modular hip replacement systems. Originally, the hip implants were thought to be far superior to traditional metal-on-metal hip replacement devices. Unfortunately, by July 2012, Stryker voluntarily recalled their hip replacement systems due to significant issues including injury and death related to DVT and other medical problems.

As a result of the failed system, thousands of individuals underwent Stryker hip revision surgery, where the original implant was removed and replaced with new components. Unfortunately, revision surgery is significantly more complicated than the original procedure, taking up to six months to fully recover. Due to the extensive recovery time and challenging rehabilitation, many patients develop a variety of complications including deep vein thrombosis.

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Femur Fracture InfectionsAn infection caused by a femur fracture is one of the leading devastating complications resulting in hip revision surgery. A periprosthetic fracture on the patient’s femur can occur by accident during revision surgery when attempting to remove the implant for replacement. However, the surgeon often has no other alternative but to purposely fracture the patient’s femur during surgery to remove the implant stem.

An infection within the hip joint and/or stem often leads to the need for revision surgery as a correction for numerous reasons, which might include:

  • Extensive pain in the patient to join
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Expectations prior and post hip revision surgeryPatients who experience a corrosion of components in Stryker hip implants may need to receive a revision surgery. As Stryker components become worn, they can release metal debris into the bloodstream. The release of metal debris can then trigger conditions like metallosis (see here) and adverse tissue reaction. If patients experience pain and swelling, these can be indicators of adverse tissue reaction. Patients who have these symptoms should speak with a physician about their options and whether they may require a revision surgery.

Diagnosing Issues Related to Stryker Hip Implants

Those who have Stryker hip implants may wish to speak with a medical professional about any issues related to the implant. Ever since Stryker Orthopaedics initiated a voluntary recall of the Rejuvenate and ABG II systems in 2012, thousands of patients have experienced pain, swelling, infection and other serious health issues as a result of defects in the Stryker hip implants.

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Different People Who are getting Stryker HipsAdverse Local Tissue Reaction in Hip Revision Surgery Patients

A recent research study completed by H. John Cooper and his associates revealed that individuals between the ages of 43 to 77 were at risk for developing metal poisoning and significant on-set pain after a revision surgery involving metal hip replacement devices. The study is entitled, “Adverse Local Tissue Reaction Arising from Corrosion at the Femoral Neck-Body Junction in a Dual-Taper Stem with a Cobalt-Chromium Modular Neck” and has been published by the Journal of Bone and Joint Surgery.

The study shows that immediately following the corrosion of metal hip replacement devices, patients reported experiencing chronic pain for a total of 8.6 months before receiving a diagnosis and revision surgery. When the revision surgery was finally performed, the pain did not stop for patients who underwent the invasive procedure. Instead, some patients suffered from worsened conditions, such as additional fractures, during or after a surgery. Other patients had hips that required an extensive trochanteric osteotomy procedure to remove a hip implant. The results of the research study also indicated increased levels of cobalt, chromium and titanium in men and women between the ages of 43 and 77 who had received revision surgeries after the corrosion of their metal hip replacement devices. These increased metal levels indicate that patients may already be experiencing forms of metal poisoning.

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Metal Poisoning in the Stryker HipThe Risk of Metal Poisoning in Stryker Hip Patients: Development of High Cobalt Levels

In an unsettling report recently published in the Journal of Bone and Joint Surgery, medical researchers discovered that disproportionate levels of cobalt placed Stryker hip patients at a severe risk of developing harmful disorders like metal poisoning. The research study was conducted by H. John Cooper and his associates at the Rush University Medical Center, Northwestern University Feinberg School of Medicine and Indiana University School of Medicine.

Contact UsThe research study tracked 11 patients who had recently undergone revision surgery after suffering from hip replacement issues, and high levels of cobalt were discovered in the bloodstream of these patients. According to the study, the average cobalt levels discovered in patients was 6.0, and the study results indicate that patients with revision surgeries had levels as high as 8.8, 8.9 and 9.5 in cobalt levels after the surgery’s completion.

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Stryker Corporation, makers of the Stryker Rejuvenate and ABG II hip replacements that were recalled in 2012, is the next company to be part of multi district litigation (MDL) for the lawsuits related to their hip recall. The New Jersey Superior Court considered the application for MDL in January 2013 and then began forming the committees and pre-trial stipulations to consolidate the recall cases in Bergen County, NJ. This is following in the footsteps of the DePuy recall, which is also a MDL in Bergen County.

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How Does MDL Work?

Multi district litigation (MDL) was formed by Congress in 1968 to handle complex civil lawsuits that are filed in several districts, consolidating them in one court. Most MDL involve lawsuits that affect many people, such as medication and medical device recalls. Once a MDL has been assigned to a product recall such as Stryker’s hip replacements, all cases related to the recall are first directed through a centralized court to go through the pre-trial and discovery process. If the case is not settled or dismissed during the MDL stage, then it would continue to trial in the original court in which it was filed.

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Stryker’s hip implants, the Stryker Rejuvenate and the ABG II, are supposed to last between 15 and 20 years. Instead, many patients are finding that they’re having problems after just two years– or less of service. In fact, some patients are experiencing pain, dislocation and other complications just weeks after the surgery.

Stryker’s first hip implant, the Stryker Rejuvenate, was first distributed in February, 2010. They issued their recall on July 6, 2012.

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The question is:

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As the over 10,000 pending civil cases await trial, the question that is being asked in litigation preparation is exactly when Johnson & Johnson’s DePuy division found out that there were defects in their product and what information did they conceal from the public? The first case has already been tried and resulted in an $8.3 million verdict for the plaintiff. The second case is already under way in state court in Chicago, IL and many more are to come that will debate the same question in front of a jury.

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Metal-On-Metal Hip Implant Problems

Although DePuy did not recall its ASR XL Acetabular metal-on-metal (MOM) hip replacement until 2010, it is being debated that they knew years earlier that there was a problem. These MOM hip implants were touted in the beginning to last 20 years for patients and now even DePuy admits that almost 40% of the implants will need to be replaced within five years of the implant. On top of the replacement or revision surgery, patients may suffer from tissue and muscle damage and may be exposed to dangerous metal poisoning as well.