In June of 2012, Stryker recalled its Rejuvenate Modular and ABG II modular-neck hip stems due to risks associated with fretting and/or corrosion around the neck hip stems which can cause adverse local reaction and/or pain and swelling around the hip.
What caused this recall and what happened since?
Let’s look at the timeline of events…
June 2008 – Stryker Rejuvenate Modular neck hip stem was approved by the FDA through the FDA’s 510(k) Premarket Notification program. Getting approval through the FDA’s 510(k) Premarket Notification program allows a company to avoid going through clinical trials for a product. The company just has to show that the product is substantially equivalent to another product on the market.
November 2009 – Stryker ABG II modular-neck hip stems is approved by the FDA through a 510(k) Premarket Notification.
May 2011 – Stryker was asked by the FDA to do a post-market surveillance study because of the risks they were seeing associated with metal-on-metal hip systems.
June 2012 – The FDA’s Orthopaedic and Rehabilitation Devices Advisory Panel meets to discuss concerns regarding metal-on-metal hip replacement systems.
June 2012 – Stryker recalls its Rejuvenate Modular and ABG II modular-neck hip stems.
January 2013 – The FDA issues a proposed order requiring manufacturers of metal-on-metal hip replacement systems to submit a Premarket Approval Application (PMA) showing the safety and effectiveness of the product instead of going through the 510(k) Premarket Notification System that the Rejuvenate Modular and ABG II modular-neck hip stems went through.
January 2013 – The FDA issues a safety communication stating that “metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.”
November 2014 – Stryker agreed to a 1.43 billion dollar settlement.
February 2016 – The FDA issues a final order order requiring manufacturers of metal-on-metal hip replacement systems to submit a Premarket Approval Application (PMA).
December 2016 – Stryker agrees to add additional patients to their class action settlement. Patients who had revision surgery prior to the November 2014 settlement are now included in the settlement.
If you or a loved one have been affected to the Stryker Hip Replacement recalls, contact the experienced defective medical device attorneys at Gilreath & Associates for your free consultation today.