Stryker Rejuvenate Hip Implant Settlement
Stryker Corp. agreed on November 3, 2014 to pay more than $1 billion to settle lawsuits over thousands of hip implants recalled in 2012 after patients complained of early hip implant failure, pain, and metal debris causing metallosis from the devices.
Stryker Settlement Details
Stryker will pay a base amount of $300,000 per case to patients who had the devices surgically removed. The hip implant device manufacturer is exposed to more than 4,000 suits consolidated in New Jersey state court and federal court in Minnesota.
To qualify for the settlement, Stryker patients must show they had their hip implant removed prior to November 3, according to the terms of the settlement.
Patients who suffered extraordinary injuries associated with the hip’s removal, such as multiple surgeries, may qualify for more than $300,000 in compensation.
Orthopedic devices giant Stryker announced recall of 2 hip implants over concerns that the devices may be prone to "fretting and/or corrosion at or about the modular-neck junction" which may lead to pain, swelling and adverse reactions in surrounding tissue.
The Dr. Shezad Malik Law Firm, is currently accepting Stryker Rejuvenate Modular hip implant injury and failure cases in all 50 states, including California, Florida, Illinois, New York and Texas.
If you or somebody you know has been injured by Stryker Rejuvenate hip implant or ABG II modular-neck system, you should contact our attorneys for a free case consultation. Please use the form to contact our Defective Hip Implant Litigation Team or call us toll-free 24 hours a day at (888) 210-9693 ext 2.
The recall affects the company's Rejuvenate Modular and ABG II modular-neck hip stems, and Stryker decided to terminate global production of the devices after discovering a potential trend in post-market surveillance data.
The Stryker Rejuvenate hip replacement device has been linked to an increased risk of metallosis. Although the Stryker Rejuvenate is not a metal-on-metal hip device, it has metal-on-metal components, which are believed to be responsible for the development of metallosis in some patients.
According to reports, the Stryker Rejuvenate hip implant device is linked to a high early failure rate, resulting in some patients having revision surgery to replace their hip replacement device.What is a Modular Neck stem?
Modular neck stems allow physicians to more accurately reproduce a patient's natural hip geometry and "can facilitate femoral component insertion in more technically challenging surgical approaches" according to a Stryker report dated 2012.
It was marketed to younger patients as a modular hip replacement, meaning the components were custom-made to fit patients better, which was supposed to result in longer-lasting hip replacement devices that offered a better range of motion.
Some patients reportedly developed metallosis after having the Stryker Rejuvenate hip device implanted. Although it was initially believed that such a condition was not possible, because the Stryker Rejuvenate does not have a metal on metal ball and socket design.
The Stryker hip device has a metal neck piece that can rub against a metal stem, causing metallic debris to come loose.What is the problem with Stryker Rejuvenate Modular Hips?
The Stryker Rejuvenate Modular Primary Hip System is a multi-piece hip replacement that has a ceramic-on-plastic design.
The Rejuvenate hip also has metal-on-metal parts, where the metal femoral neck contacts the metal femoral stem. Usually in other hip implants, the neck and stem are manufactured as one solid piece.Stryker Rejuvenate Modular Hip History
The Rejuvenate hip implant was approved by the U.S. Food and Drug Administration (FDA) in 2008 and was first sold in 2009.
The Stryker Rejuvenate metal on metal hip implant was fast-tracked under the FDA’s 510(k) system approval process. Stryker claimed the Stryker Rejuvenate Modular Hip was “similar” to other older hip devices and so they never conducted long-term safety studies of the metal hip.Stryker Rejuvenate Hip Recall
On July 4, 2012, Stryker posted a voluntary recall notice on its website announcing the recall of the Stryker Rejuvenate hip implant. The defective part of this device includes the femoral stem, this part is impacted into a patient’s femur.FDA MAUDE Adverse Reports
The U.S. Food and Drug Administration’s MAUDE Adverse Event Report System has documented several reports that have linked the recalled products to adverse modular-neck stem side effects. One report tells of a patient who experienced metal sensitivity to the rejuvenate modular-neck stem. Another patient required revision surgery due to the pain of the ABG II Modular short neck.
Read the FDA Safety WARNING HERE http://www.fda.gov/Safety/Recalls/ucm311043.htmStryker Issues Safety Warning
In May 2012, Stryker sent an Urgent Field Safety Notice to orthopedic surgeons who might implant the Stryker Rejuvenate or ABS II hip implants. The company warned of the following potential hazards:
- Excessive metal debris from corrosion
- Metallosis, metal poisoning, tissue damage and inflammation
- Bone loss due to inflammation
- Pain and tenderness at the hip joint
- Inflammation and swelling at the hip joint
- Decreased mobility and walking ability
- Metallosis (toxic metal poisoning)
- Corrosion of the hip implant
- Loosening of the hip joint
Our law firm’s principal office is in Dallas and we have offices in Fort Worth, Texas. Dr Shezad Malik Law Firm represents clients in dangerous drug and dangerous medical device lawsuits nationwide.Contact Dr Shezad Malik Law Firm
If you or a loved one had a Stryker Metal on Metal Hip Implant and have suffered injuries or wrongful death with the device, contact the attorneys at Dr Shezad Malik Law Firm to learn more about your legal rights. You can speak with one of our representatives by calling toll-free at 888-210-9693 ext. 2 or 214-390-3189, or by filling out the case evaluation form on the right of this page.
Our law firm’s principal office is in Dallas and we have offices in Fort Worth, Texas. Dr Shezad Malik Law Firm represents clients in dangerous drug and dangerous medical device lawsuits nationwide.