Hip Replacement Recall Stryker Rejuvenate
Stryker finally recalls faulty hip replacement joint “Rejuvenate”
After faced with mounting evidence of complications in hundreds of patients, in July 2012 Stryker finally admitted design flaws in its Rejuvenate Modular Hip System and announced a “voluntary” recall.
Stryker Rejuvenate recalled
The Stryker Rejuvenate joint, that has a metal neck piece that can rub against a metal stem causing metallic debris to come loose, was experiencing corrosion which led to muscle damage, complete implant failure, and often permanent damage.
Victims who do not have much faith in Stryker’s recall or plans to remedy this tragic mistake are taking legal action because of some very clear evidence that Stryker failed to practice due diligence before releasing this product to the market. Once it is proven that Stryker put company profits ahead of public safety then legal action will be the best means for victims to obtain the justice they deserve.
Stryker Rejuvenate hip has to be replaced
Patients who have used the Stryker Rejuvenate joint have experienced the effects of corrosion 8 to 14 months after the device was installed. The corrosion leads to an inflammation that destroys the tissue around the joint which then has to be replaced again. And so this joint that is supposed to last up to 15 years is failing in its first or second year.
“When Stryker issued its recall the company sent out letters to all physicians who had ordered their faulty joint and the physicians then sent letters to patients suggesting they call the doctor’s office if they are experiencing any problems,” says Terry Cochran, senior partner of Cochran, Kroll & Associates, PC. “After looking at the evidence, there is no question in my mind but that every patient who has this hip joint inside them will develop problems. And many are suffering from a limp that will remain even after the joint is replaced again.”
Symptoms of the Stryker hip replacement failure
Thousands of patients have been implanted with the Stryker Rejuvenate joint in recent years and the number of those with failed implants is mounting as the months pass. Some of the symptoms and problems related to use of the joint include:
- Wear and tear of the hip implant
- Loosening, breaking or failure of the implant
- Metal poisoning
- Premature death of tissues surrounding the joint
- Bone deterioration around the implant
- Formation of pseudo-tumors
- Severe pain and/or swelling at the joint
- Other health problems caused by the spread of metal particles in the blood stream
Eileen Kroll, partner at Cochran, Kroll & Associates and a Registered Nurse, cautions that most of the above symptoms can lead to serious medical issues if left untreated. She urges anyone with a Stryker hip joint to call their doctor or surgeon immediately and then call an attorney.
Lawyers at Cochran, Kroll & Associates have been compiling evidence of Stryker’s complicity in this tragic failure and are conducting an ongoing national case review of lawsuits in progress in the judicial system.
Stryker implants are different
The Stryker implants are different in that they allow surgeons to correct aspects of a patient’s anatomy in an attempt to offer a more personalized fit for each patient. But despite their adjustable design, the Stryker components faced issues almost immediately after being brought to market. Recipients complained of pain, swelling, reduced mobility, and issues with metal poisoning.
The fact that Stryker implants are individually adapted to each patient’s body type complicates any effort to replace the Stryker joint with another brand. Thus, when a different brand is used the Stryker patient will experience an even lengthier recovery timetable and might never regain the mobility they had with the Stryker joint.
Delay in recalling the Stryker hip replacement
As is the case with most implant failures, Stryker waited a long time after evidence began appearing before recalling its faulty product. In fact, patients complained of pain, swelling and other symptoms for three years before Stryker recalled its product – a delay that allowed thousands more patients to receive an implanted joint that was known to be flawed.
Although the recall was voluntary, the FDA had been listening to complaints from consumers and in response inspecting Stryker’s manufacturing facilities since 2007. Among the problems the FDA found in 2007 (five years before the voluntary recall) were deficiencies in quality control stages of manufacturing and the presence of disease-causing germs including clusters of a form of Staphylococcus bacteria.
FDA issues warning to Stryker
As a result, in November 2007 the FDA warned Stryker that if it did not correct these problems the FDA would seize property at the manufacturing plant, file injunctions, and warn government agencies not to award contracts with Stryker because of the problems discovered. While the problems the FDA found at the Stryker plant may or may not be related to the joint failures, the fact remains that Stryker did not recall the joint until after being warned by the FDA and after thousands of more joints continued to be made.
“What these facts do point to is that patients and family members cannot rely upon Stryker to do the right thing when its products fail and victims are experiencing great suffering,” says Cochran. “In many of our malpractice cases involving faulty medical hardware, toxic drugs, and bad procedure we find that the guilty party waits months and months before doing the right thing while victims suffer needlessly. This is intolerable! The fact is the victim of a faulty joint placement will not feel good simply because the manufacturer asks for another chance to make it right,” says Cochran.
“Having hip replacement is always strenuous to go through, including the weeks of rehab following surgery, but it is tragic and more grueling when the patient must have the hip replacement redone because of a replacement joint recall,” adds Cochran.
The Law Offices of Cochran, Kroll & Associates, P.C. is dedicated to representing individuals and families who have suffered catastrophic losses as a result of injuries, disabilities and death. The firm does not represent insurance companies or corporations but instead bases its practice upon representing individuals and families.