Stryker Hip Recall
One of the world’s premier medical technology companies, Stryker was founded in 1941 by Dr. Homer Stryker, and was initially known as “The Orthopedic Frame Company.” Over the past nearly 75 years, Stryker Orthopaedics has provided reconstructive, medical and surgical, and neurotechnology and spine products to help patients continue to live active lives.
With over 22,000 employees worldwide, Stryker has found great success in producing hip implants for use during total hip replacement surgery and hip resurfacing surgery. Two Stryker hip recall actions, however, marred their reputation in 2008 and 2012, alerting patients that the company had failed to properly test their products for public safety before releasing them on the market. Many recipients of Stryker hip replacements suffered unnecessary injuries before these recalls were implemented, and have since gone on to file lawsuits against the manufacturer, seeking compensation for their injuries, pain, and suffering.
The first Stryker hip replacement recall
The first Stryker hip recall occurred in 2008, when the company recalled certain components from the Trident hip system. Stryker and the FDA had been receiving reports of hip replacement complications with the implant, with patients complaining of popping and squeaking noises, pain, difficulty walking, component breakage, and broken bones.
Approved by the FDA in 2003, the Stryker Trident hip implant was made of ceramic materials that were designed to give patients longer wear and durability. Starting in 2005, however, evidence began to point to a less-than-desirable outcome of this design.
- 2005-2007: Starting in 2005, the complaints began to come in to the FDA about problems with the Trident hip implant. Patients and physicians reported problems like those mentioned above. Some patients had to go through revision surgery to remove the device and replace it with a new artificial hip.
- March 2007: On March 15, 2007, the FDA issued a warning to Stryker. They had just finished an inspection of the Cork, Ireland manufacturing facility, and discovered that the facility was not conforming with certain good manufacturing practices, specifically as they related to the manufacture, packing, storage, and installation of the Trident implants. Secondly, they had not established or maintained any sort of process to fix problems with the products or to address any of the health risks associated with them.
- November 2007: On November 28, 2007, the FDA sent a second warning letter to Stryker. At an inspection of the Mahway, New Jersey manufacturing plant, the agency had again found problems. As in the Ireland facility, the New Jersey facility had failed to establish any sort of process to analyze and fix the problems occurring with any of their products, including the Trident hip implant—or to address any other quality problems. The FDA also admonished Stryker for not properly addressing the complaints about the Trident specifically, including the reports of popping and squeaking noises and the “improper seating” of the implants, which was believed to be the cause of bone fractures.
- January 2008: On January 22, 2008, a Stryker hip replacement recall was ordered for certain Trident components manufactured at the Cork, Ireland facility: the Trident Acetabular Cup System and the Trident Hemispherical Cup System. Both of these components had been linked to the hip complications reported to the FDA. Stryker stated these components had manufacturing defects.
Stryker issues second hip recall
In 2008 and 2009, the FDA approved both the Stryker Rejuvenate and the Stryker ABG II modular-neck stem hip systems for use in hip replacement surgery. This approval was not achieved through a demonstration of safety in clinical trials, however, but through the FDA’s fast-track 510(k) system, which required only that the company prove the products substantially similar to others already on the market.
These products were somewhat different, however, from standard hip stems. Instead of being the typical one-piece stem and neck “monoblock” design that is inserted into the femur (thigh bone), these were two-piece neck and stem components, with numerous options for each. The company advertised the new design as being more flexible and effective for patients, since it allowed doctors more options when fitting patients with different body shapes and sizes. Both parts of the system were made of metal, which would later prove problematic.
Timeline leading up to the Stryker Rejuvenate and ABG II hip recall:
- 2008-2009: Stryker receives FDA approval of both the Rejuvenate and ABG II modular-neck stem hip systems. Both were approved through the 510(k) process, which requires no clinical trials to establish safety.
- 2009-2012: Stryker marketed the new Rejuvenate system as being ideal for younger, more active patients, since they allowed the physician to adjust the length to create the perfect fit. The ABG II system was marked as supposedly offering more stability and minimal bone stress. In addition, the metal materials were supposed to provide longer wear and tear.
- 2011-2012: The company and the FDA started to receive reports of complications with the modular-neck systems. These included problems like loosening of the implant, dislocation, swelling, pain, immobility, and premature hip failure leading to necessary revision surgery.
- February 2012: The British Medical Journal publishes an article noting that certain metal-on-metal hip implants could release metal ions into the surrounding joint area and into the bloodstream at a higher level than previously thought, and that the ions could destroy muscle and bone.
- April 2012: Stryker released an “Urgent Safety Alert” to physicians, notifying them of the potential problems with the Rejuvenate and ABG II systems. In the release, they stated that it was possible for the two parts of the modular-neck stem to work back and forth against one another, causing “fretting and/or corrosion at or about the modular neck junction….” They added that this fretting could release metal ions into the surrounding joint space, which could cause “Adverse Local Tissue Reaction (ALTR), the inflammation of associated tissues experiencing immunological response (metallosis, necrosis, and/or pain.” They went on to state that ALTR may “result in the need for revision surgery.”
- May 2012: On May 28, 2012, Health Canada announced a Stryker hip recall of certain Rejuvenate modular neck components for the purposes of updating the instructions for implantation.
- July 2012: Stryker implemented a voluntary recall of both the Rejuvenate and ABG II modular-neck systems. They stated on their website that the recall “was initiated due to potential risks associated with modular-neck stems. These risks include the potential for fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reaction, as well as possible pain and/or swelling, in and around your hip.” The company suggested that those patients who had been implanted with either of these products schedule a follow-up appointment to analyze the implant’s performance. They added, “your surgeon will be able to evaluate how your hip implant is functioning and whether further testing is necessary.”
Legal options for those affected by the Stryker hip replacement recall
Patients who were implanted with a Stryker Trident, Rejuvenate, or ABG II hip implant system and then later experienced serious complications may be eligible to file a lawsuit to recover damages. Many patients have already filed Stryker hip lawsuit complaints around the country, claiming the manufacturer should have provided better warnings about the risks, and further, should have conducted additional safety studies on the components before releasing them onto the market. Stryker hip attorneys across the country are currently investigating claims for possible future litigation.
Stryker Trident lawsuits have been centralized in Atlantic City Superior Court in New Jersey, where both parties have resolved many cases already. In June 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Stryker Rejuvenate and ABG II lawsuits into one court as multidistrict litigation. Such consolidation could increase the efficiency of pre-trial proceedings, as well as reduce the risk of inconsistent rulings.
- Stryker Orthopaedics, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076583.htm
- NY Times, http://www.nytimes.com/2008/05/11/business/11hip.html?pagewanted=all&_r=0
- Stryker Says Hip Recall to Cost Up to $390 M, http://www.reuters.com/article/2013/01/09/stryker-recall-idUSL1E9C95FG20130109
- Stryker Initiates Voluntary Product Recall of Modular-Neck Stems, Action Specific to Rejuvenate and ABG II Modular-Neck Stems, http://www.fda.gov/safety/recalls/ucm311043.htm