Stryker Hip Implants Recall: Information and Warnings
Stryker Corporation is a medical device manufacturer that issued a voluntary recall of its Rejuvenate and ABG II hip implants. Coming on the heels of a 2007 recall of similar hip implants, the recall of Rejuvenate and ABG II hip implants is the second major recall issued by Stryker in the last 5 years.
2012 Stryker Recall
Stryker’s Rejuvenate and ABG II models were released onto the market without testing under a 510(k) Premarket Notification, the FDA’s rule that allows companies to bypass testing for new products that compare to existing ones. Without premarket testing, Stryker's newest hip implants were used in patients before the company or experienced physicians understood the potential side effects. In effect, the hip patients who received Rejuvenate and ABG II models were the test subjects, and, unfortunately for them, the new models carried serious risk for injury. In July 2012, after widespread use of the new hip implants, Stryker issued a voluntary recall citing the following defects
- Under certain conditions, metal components in the neck and stem of the Rejuvenate and ABG II models rub together. This causes metal shards to enter the surrounding tissue, and creates inflammation, pain, and possible joint failure. The condition, known as metallosis, can be fairly difficult to detect and its full effects are not known – any patient who had a Stryker hip implant installed should consult a doctor immediately
- The breakdown of the metal components in the new hip implants creates the need for major revision surgery less than 2 – 3 years after they are initially installed. The surgery repairing defective Stryker hip implants is invasive, causes serious pain, and significantly lengthens the patient’s recovery time.
With the recall being issued so recently, there are likely several patients who have yet to exhibit symptoms of the side effects associated with Stryker’s Rejuvenate and ABG II products. If you or a loved one has been injured by a Stryker hip implant, or have required expensive revision surgery sooner than expected, contact an experienced attorney immediately. Lawsuits against Stryker have already been filed, and the issue will be ongoing as more patients come forward with injuries related to defective Stryker hip implant.
In 2008, Stryker issued a recall of its Trident Acetabular PSL Cup and its Trident Hemispherical Cup hip implant products. The FDA cited the following concerns that led to the company issuing the recall:
- Failed fixation of hip implant components requiring revision surgeries;
- Squeaking noises from hip implant components requiring revision surgeries;
- Improper seating of the hip implants resulting in bone fractures;
In addition to the problems associated with the hip implants themselves, during an FDA investigation held during the summer of 2007, FDA inspectors found the manufacturing site deficient with regard to some of its quality control procedures. Disease-causing germs were found at the facility, including clumps and clusters of a form of Staphylococcus bacteria.
Getting Legal Help
If you or a loved one has experienced troubles related to a Stryker hip implant product, contact a Stryker Hip Implant attorney immediately. You may seek compensation for your injuries, but only if you act within the statute of limitations, the time limit imposed by state laws for filing a Stryker Hip Implant lawsuit, or any personal injury lawsuit. To have your case evaluated right away by an experienced Stryker Hip Implant lawyer, fill out this case evaluation form.
Check out the following articles for more information about Stryker Hip Implants, filing a Stryker Hip Implant lawsuit and finding a Stryker Hip Implant attorney.
- For more information about Stryker Hip Implants, see Stryker Hip Implants: Overview & Claims.
- For more information about Stryker Hip Implant problems, such as pain, squeaky joints and/or bone fractures, see Stryker Hip Implant Problems: Pain, Squeaky Joints & Bone Fractures.
- If you would like to learn more about Stryker Hip Implant lawsuits and see how an attorney can assist you, see Stryker Hip Implant Lawsuits, Litigation & Lawyers.