Stryker was formed in 1941 by Dr. Homer Stryker. He invented the first
mobile hospital bed, known as Circ-O-Lectric. After his retirement, Stryker
left his son in charge as general manager of Stryker Corporation. In 1979,
this company entered the orthopaedic implant industry and eventually split
into three segments; surgical, medical, and osteonics.
Stryker Corporation bought an orthopaedic division of Pfizer and became
well known for its Stryker Knee 1.0. Another popular product, the CentPillar
hip stem, was released to the Japanese market in 2003. By 2010, this business
held approximately 25 percent of the artificial hip and knee markets in
the United States.
Medical Devices Recalled Against Stryker Corp.
Numerous Stryker medical devices have been recalled. Its Neptune Rover
Waste Management System was recalled in 2012. This product was used to
collect and dispose of surgical fluid waste from operating rooms. The
Neptune 2 Ultra removed smoke generated by laser operating devices as
well. Both items used mobile rover units that could be relocated to specified
waste designated areas. The reason for these recalls stemmed from two
reports of serious tissue damage that occurred from use.
Another massive class II recall came from its EIUS knee replacement device.
It was reported this product had a much higher than normal failure rate
as compared to other kinds of knee implants. This resulted in painful
revision surgeries for affected patients. One year later, there was a
similar recall of Stryker’s ShapeMatch System, a different knee
The main reason behind many of these knee replacement recalls is the FDA’s
“fast-track” approval process. This allows new medical devices
to be pre-marketed if they are “substantially equivalent”
to existing approved devices. This allows a product to circumvent premarket
testing and various safety measures. Unfortunately, there is an additional
loophole in this process. When an older approved device is recalled, the
new device may still remain available.
Alongside its many knee implants, Stryker offers a variety of hip implants
as well. Its Trident hip systems, which were made from ceramic-on-ceramic
parts, were the first to come under fire. In 2007, the FDA began investigating
the company’s New Jersey manufacturing facility and uncovered a
number of deficiencies that led to the production of defective devices.
In 2008, Stryker issued a voluntary recall of parts in its Trident line.
On July 6, 2012, Stryker voluntarily issued another recall on its Rejuvenate
and ABG II Modular and Neck Stems. Potential risks that led to this recall
included fretting and metal corrosion. Patients who suffered from hip
replacement failure experienced symptoms similar to the flu, blurry vision,
and tumorous growths in the hip region. Stryker recommended patients who
received either of these devices to contact their surgeons and schedule
Lawsuits Facing Stryker Corp.
Various patients who received Stryker knee implants reported pain and other
problems following surgery. Knee implant manufacturers are legally responsible
for marketing products correctly and providing adequate warnings regarding
risks. They are also supposed to monitor the safety of all products after
they have been FDA approved. Many people have started filing lawsuits
against Stryker and feel this company must be held responsible for its
Besides knee implants, Stryker is facing problems from patients who received
its hip implants. By 2012, it became clear that the Rejuvenate and ABD
II modular-neck hip stem implants reacted poorly when placed in the body.
These products were found to deposit shards of metal into surrounding
bone, tissue, and the bloodstream. Although Stryker was allowed to market
these items without premarket testing, the company still had an ethical
obligation to the public. Instead of ensuring a safe product, it exploited
patients and received financial gain. Many innocent victims are coming
forward to file claims against Stryker and its products.
If you or a loved one has suffered problems associated with a Stryker hip
replacement device, it is imperative to consult with an attorney as soon
as possible. Each state has a different statute of limitations regarding
the Stryker lawsuits. It is important to receive fair compensation for
your suffering at the hands of a negligent company.
Verdicts Against Stryker Corp.
In May 2012, Stryker was faced with scrutiny over its knee devices. The
United States Department of Justice subpoenaed the company for sales and
marketing practices associated to its OtisKnee. After negotiations, Stryker
agreed to pay a $33 million settlement.
In November 2014, Stryker agreed to settle thousands of claims related
to its hip implant products. It is estimated that the verdict ordered
Stryker to pay $1.43 billion. Since this amount is not capped, experts
believe the final payout will exceed this total. The settlement includes
claimants who had surgery prior to November 3, 2014. The initial payouts
should begin in the summer of 2015.
Besides lawsuits over faulty products, Stryker faced other legal woes.
In the fall of 2013, the U.S. Securities and Exchange Commission fined
the corporation $13.2 million amidst allegations the manufacturer wrote
off $2 million in bribes, charitable donations, and travel expenses. For
instance, internal information surfaced that proved a hospital director
was given a six-night stay in New York City with Broadway tickets to “strengthen
the physician’s beliefs” that Stryker products should be used
in her facility. Transactions of this nature were logged as legitimate
expenses in the company’s record books.
FDA Sanctions Against Stryker Corp.
In 2005, the FDA became aware of problems with Stryker’s products,
especially its implant devices. An unusually high number of knee implant
patients reported serious complications after surgery, including squealing
joints, implants that chipped, extreme pain, and difficulty walking. Some
patients suffered bone fractures as well. In 2007, the FDA warned Stryker
to correct procedural failings and better document risks. After the voluntary
recall was issued, concerns were raised about the company’s quality control.
Once again, Stryker received a warning letter and inspection from the FDA
in 2013. This letter questioned quality issues at its Portage, Michigan
plant. The federal organization noted Stryker did not notify the regulator
of any recall and was marketing its Neptune device without required approval.
Despite these warnings, Stryker plans to continue developing new implant