Each year in the U.S., over 300,000 hip surgeries are performed to replace worn or damaged hip joints with artificial hip replacement devices. Even though these devices are intended to improve functioning and mobility, many patients who have gotten a Stryker hip implant, are faced with early device failure, resulting in complications and a need for revision surgery.
The Stryker company, one of the largest medical device manufacturers whose products include a number of artificial joint replacement products, has faced thousands of lawsuits for injuries caused by their devices.
Involved products which have been recalled and resulted in high numbers of injuries include:
- Stryker ABG II System
- Stryker Rejuvenate System
- LFIT Anatomical CoCr V40 Femoral Head
- Tritanium Acetabular Shell
Many of these lawsuits have settlement offers, however hundreds of cases are still pending.
Stryker Hip Metal-on-Metal Construction
Stryker hip replacement products which have caused serious complications in a number of patients are metal-on-metal (MoM) devices which are similar to other devices that have been recalled.
Metal-on-metal devices are constructed of various metal alloys including chromium, cobalt, and titanium. Metal surfaces which were intended to be sturdier and longer-lasting, can create serious problems due to metal fragmentation and shedding that occurs when surfaces grate against one another.
Metal fragmentation and shedding causes complications in the area of the hip device, but also can result in body-wide immune reaction from metal ions which have been absorbed into the bloodstream.
Stryker Hip Implant Complications
Largely due to the metal-on-metal device type and metal alloys chosen for device construction, many of the complications caused by Stryker Hip Implants are metal-related.
Complications due to Stryker Hip Implants may include:
- Severe or chronic pain
- Inflammation
- Rash
- Infection
- Osteolysis
- Necrosis
- Joint dissolution
- Hip dislocation
- Implant detachment
- Flu-like illness
- Pseudotumor formation
Implant failure due to metallosis or other complications will generally require a hip revision surgery to repair damage, remove failed device and replace it with a new artificial joint. In some cases, multiple surgeries may be required.
Stryker Hip FDA Approval Shortcuts
Stryker implants were approved under the FDA’s 510(k) Premarket Notification Process, a fast-track process. The program provides an exemption to manufacturers allowing them to avoid expensive clinical trials on new products that are similar to something already approved for the market.
This approval process meant the ABG II and Rejuvenate hip replacement and other devices did not undergo implantation in humans during a clinical testing phase. By the time the FDA began to receive adverse event reports about the devices, thousands of hip devices were already in use and hundreds of people were suffering complications.
The company issued a recall for the ABG II and Rejuvenate hip implants and discontinued manufacturing in 2012, less than 4 years after the devices entered the market but many people had already been harmed. In 2016, Stryker issued an alert for some sizes of the LFIT V40 Femoral head devices and later recalled and discontinued the device but Stryker Tritanium Acetabular Shell and Cup is still in use.
Stryker Hip Recall Timeline
Due to a high number of Adverse Event occurrences, the Stryker company was forced to issue voluntary recalls for the Rejuvenate and ABG II modular neck system just a few short years after the devices had been approved.
- 2008 – Stryker Rejuvenate modular-neck hip stem approved by FDA
- 2009 – Stryker ABG II modular-neck stem approved by FDA
- 2010 – Stryker issues “urgent field safety notice” to surgeons discussing 1 percent failure rate due to metallic particles but fails to notify patients of potential problems.
- 2012 – Stryker issues “urgent field safety notice” to surgeons and hospitals with alert regarding potential hazards of metallic debris.
- 2012 – Health Canada issues recall for Stryker Rejuvenate Hip Implant in Canada
- July 2012 – After reports begin accumulating at FDA, Stryker issues voluntary recall for both Rejuvenate and ABG II modular neck system. Asks patients to contact surgeon and company.
- 2016 – Stryker issues safety alert for LFIT V40 CoCr Femoral head due to potential vapor lock issue. The device was later recalled and discontinued.
Company Evasive Action to Avoid Lawsuits
In addition to recalls issued by Stryker, the company preemptively offered to reimburse patients for some medical testing and removal procedures related to Rejuvenate devices. The company also hired Broadspire, a claims management company that works to settle cases quickly before those injured by Rejuvenate devices had an opportunity to explore all of their options.
A number of people implanted with the Rejuvenate and ABG II devices received letters informing them of Broadspire’s handling of claims for patient expenses related to their device. According to Stryker’s website, “Stryker will be reimbursing patients for testing, treatment, revision surgery, if necessary, and other costs relating to this voluntary recall.” Stryker also directed doctors throughout the country to inform patients they should contact Broadspire or Stryker to discuss their case. This practice may have deprived some affected patients of adequate assistance.
Stryker Hip Lawsuit Settlements
Stryker has faced thousands of lawsuits for complications caused by its hip implant devices. Some of these lawsuits have been settled but others remain in federal, state, and local courts.
In 2014, thousands of lawsuits filed for injuries caused by the Stryker Rejuvenate modular-neck stem device were settled for a total of $1 billion. The original settlement offer was later extended and included both the Rejuvenate and ABG-II modular-neck hip stem devices for a total estimated amount of $1.4 billion at a rate of about $300,000 per plaintiff, depending upon individual circumstances. A third settlement period was again extended but Stryker’s problems continued to emerge.
In 2016, the U.S. Food and Drug Administration (FDA) issued a recall of the Stryker metal LFIT V40 femoral head which had also caused an alarming number of serious injuries. The device was withdrawn from the market and has since been the subject of numerous lawsuits. Many of these lawsuits were settled in 2018 for undisclosed amounts, however some may remain in federal and state courts.
Stryker is also facing multiple Tritanium Acetabular Shell and Cup lawsuits over injuries caused by the partial hip replacement device. Lawsuits began in 2019 however no settlements have been announced.
The company has also been sued by its malpractice insurance company after insurance claims for lawsuits related to Stryker’s replacement devices were exhausted. As of January 2021, the company has indicated that up to 96% of the eligible patients for the third period of the Stryker Modular Hip Settlement may have been reached. Others still remain in court systems.