Stryker Hip Replacement Recall Report: Recalls Up 97%
Patients who were implanted with one of two devices involved in the Stryker hip replacement recall may have experienced hip dislocation, pseudotumors, muscle injuries and other complications resulting from the allegedly defective modular-neck hip stems. Contact the American Injury Attorney Group today if you or someone you love was fitted with the ABG II or Rejuvenate hip implants and you experienced adverse side effects. You may be able to seek compensation for your injuries.
Medical Device Recalls Increase
Several manufacturers of knee and hip implant devices have been named as defendants in lawsuits filed by plaintiffs alleging serious and life-threatening complications due to the manufacturers’ devices. According to those injured, these devices were approved by the U.S. Food and Drug Administration’s 510(k) clearance process, which allows products to be placed on the market even if they have not been sufficiently tested or evaluated as long as the manufacturer can prove that the new product is substantially similar to one already approved by the FDA. Plaintiffs claim that it is this lack of testing that can result in the approval of potentially dangerous and defective medical devices.
According to a report issued by the FDA’s Center for Devices and Radiological Health, the number of medical device recalls has nearly doubled in the last decade between 2002 and 2012 and now remains at 97 percent. The CDRH asserts that this is a positive increase as it demonstrates a high awareness on the part of the manufacturers in terms of product safety and efficacy.
The CDRH also reports that medical device recalls are issued for one or more of the following reasons:
- Design flaws
- Component problems
- Non-conforming materials
- Software issues
Additionally, the FDA categorizes medical device recalls into one of the following classes:
- Class I: Used for dangerous or defective products that could result in life-threatening injury and death.
- Class II: Used for dangerous or defective products that could result in temporary health problems or a small risk of injury.
- Class III: Used for dangerous or defective products that substantially violate the FDA’s labeling and/or manufacturing regulations.
Stryker Hip Replacement Recall Issued
The Stryker hip replacement recall was announced on July 6, 2012 after Stryker received post-market surveillance data indicating that the metal parts of the hip implants could potentially corrode, fret and cause patient injury. Before the Stryker hip replacement recall was issued, the FDA reportedly received 45 reports from patients in 2012 alone who allegedly sustained injuries due to the ABG II and Rejuvenate systems.
According to those filing Stryker hip replacement recall lawsuits, plaintiffs have allegedly suffered difficulty walking, inflammation, pain and trouble standing or moving the legs. Hip implant failure may also damage one’s bones, joints, soft tissues and nervous and adversely affect his or her sensitivity to metal. In many cases, patients are required to undergo complex and painful revision procedures to remove the hip – a procedure that is more difficult the second time due to an increased risk of hip dislocation.
Do You Have Questions about the Stryker Hip Replacement Recall?
If you have been fitted with the Stryker Rejuvenate or ABG II hip implant and you suffered from adverse complications or life-threatening injuries, the American Injury Attorney Group can review your case, free of charge, and help you determine if you have a claim. We can help answer your questions and connect you with an affiliated attorney who can handle your Stryker hip replacement recall claim. You may be eligible to seek compensation for damages including pain and suffering, medical expenses and lost wages. Contact us today if you feel you have a claim, as the time to file a lawsuit is limited.