Stryker Orthopaedics Overview
Stryker Corporation is a multibillion-dollar company, ranked as the largest orthopedics manufacturer in the world. Stryker employs about 46,000 people and had a 2021 revenue of about $17.1 billion. Stryker Orthopaedics, part of the Stryker Corporation, may be most well-known for their shoulder, knee, and hip replacement devices but also has expertise in the development and manufacture of specialty surgical products and other medical products.
In addition to the joint replacement devices, Stryker manufactures electrically powered surgical instruments, systems for use with bone repair, endoscopics, and orthopedics patient care supplies. The Stryker Corporation also has products that focus on surgical and medical equipment, neurotechnology, hospital and care solutions and training programs for physicians, nurses, and medical staff.
The History of Stryker
Stryker was founded by Orthopedic Surgeon, Dr. Homer Stryker in 1941 in Kalamazoo, Michigan. Before founding his company, Dr. Stryker spent eight years in general practice and did not enter the field of orthopedics until he was 45 years of age. By that point, he had discovered a number of medical products in use were not as effective as he would like them to be and began working to change that.
The first Stryker product, the Wedge Turning Frame was invented while Dr. Stryker was still completing his orthopedics training. The Turning Frame was a mobile frame which attached to a hospital bed and allowed caregivers to turn back injury patients while keeping the spine immobilized. By 1947, invention of orthopedics surgical instruments had also begun with a patented oscillating saw which cut through cast material, but not human tissue.
Development and expansion continued through the next decades and the company went public in 1979, just prior to Dr. Stryker’s death. In the 1990s, Stryker acquired a number of companies including Dimso SA, Osteo SA, and Howmedica, and also introduced RUGGED ambulance cots allowing for expansion into emergency medicine.
The acquisition of Howmedica made Stryker Orthopaedics into one of the chief competitors of the joint implant market and the company continued expansion with acquisition of:
- Ascent Healthcare
- Boston Scientific’s Neurovascular division
- Trauson Holdings Company
- MAKO Surgical
- Pivot Medical
- Patient Safety Technologies
- CoAlign Innovations
- Berchtold Holding
- Small Bone Innovations
- Sage Products
- Physio-control International
- Entellus Medical
- K2M Group Holdings
The company is now the largest manufacturer of orthopedics products but also holds a significant place in the medical device market as a whole.
Stryker Orthopaedics Implants Recalls and Lawsuits
Currently, Stryker controls about one-quarter of the knee and hip replacement market and more than 16 percent of worldwide orthopedic market. Unfortunately, a number of Stryker’s hip and knee implant patients have experienced serious side effects from their joint replacement devices. Stryker has faced thousands of lawsuits filed by people who received Stryker Rejuvenate and ABG hip implants and the company has faced penalties from the U.S. Department of Justice over improper marketing claims for their knee devices.
Stryker Hip Replacement Lawsuits
Stryker Orthopaedics hip implants were based on a novel design using modular necks with stems which allowed surgeons to custom select the components of the device for each patient. Two Stryker hip replacement devices, the Rejuvenate and the ABG II were said to offer better flexibility and stability over other products on the market, however, they proved to be problematic to patients and resulted in serious injuries.
The hip implant devices were made of a metal alloy that resulted in the release of metal fragments and ions into the joint tissue. The metal fragments and ions released from the implants led to irritation of nearby tissues and entered bloodstreams, and may have resulted in device failure and severe health effects to patients.
In July 2012, Stryker Orthopaedics recalled and pulled Rejuvenate and ABG hip devices from the market because of “fretting and corrosion. In total, an estimated 55,000 implants were recalled and injuries resulted in the filing of 4,000 Stryker hip ABG II and Rejuvenate hip lawsuits. This resulted in settlements of $1.43 billion in 2014, which was later expanded to an estimated $2 billion. Hundreds of lawsuits may not have been settled and may be pending in court systems.
Following the ABG II and Rejuvenate lawsuits, Stryker is now facing nearly 3,000 additional lawsuits filed for the LFIT Metal V40 femoral head hip implant. The LFIT Metal V40 femoral head has reportedly caused bone and tissue damage due to excessive wear, metallic debris, and device failure due to dislocation of femoral head or fracture of hip stem.
The LFIT V40 Cobalt-Chromium femoral head was subsequently recalled and in 2018, Stryker reportedly reached settlement on a number of the LFIT hip implant lawsuits, but some may still be pending and more could be expected.
Stryker Knee Implant Criminal Penalties
Stryker subsidiary, OtisMed and its CEO was accused of distributing non-FDA approved knee replacement devices prior to OtisMed’s acquisition by Stryker. OtisKnee, Stryker Orthopaedics Total Knee, Scorpio CR, and Scorpio PS components were all either partially or totally recalled and the company was also accused of defrauding the Medicare, TRICARE, Federal Employees Health Benefits and Medicaid programs by billing for unapproved devices.
In 2015, Stryker and its subsidiary, OtisMed was subpoenaed by the U.S. Department of Justice (DOJ) for the OtisKnee and was forced to pay more than $80 million, while CEO Charlie Chi was sentenced to two years in prison. The company had also previously been required to pay $16.6 million to the DOJ for actions taken by a former subsidiary, Physiotherapy Associates who had been accused of false-billing federal health care programs and the company also had to submit to an 18-month supervision because of allegations that surgeons were being paid to use their devices.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- Stryker History, Stryker (2022)
- About Us, Stryker (2020)
- Five Companies in Hip and Knee Replacement Industry Avoid Prosecution by Agreeing to Compliance Rules and Monitoring, U.S. Department of Justice (11/2007)
- Stryker Corp. & Physiotherapy Associates to Pay U.S. $16.6 Million for Alleged False Claims to Federal Health Care Programs, U.S. Department of Justice (11/2007)
- $1.4 Billion Settlement Announced in Artificial Hip Litigation, StarTribune (12/2014)
- Former OtisMed CEO Sentenced for Selling Unapproved Surgical Devices, U.S. Department of Justice (06/2015)