Stryker Orthopaedics Overview
Stryker Orthopaedics, part of the Stryker Corporation, is known for the development and manufacture of specialty surgical products and other medical supplies for health care around the globe. Stryker manufactures electrically powered surgical instruments, orthopedic implant devices, systems for use with bone repair, endoscopics, and orthopedics patient care supplies.
In addition to the orthopedics division, the Stryker Corporation, also has products that focus on surgical and medical equipment, neurotechnology, hospital and care solutions and training programs. Stryker Corporation is a multibillion-dollar company, ranked as the largest orthopedics manufacturer in the world, with about 33,000 employees and a 2019 revenue of about $13.6 billion.
Though the company manufactures hundreds of products, Stryker Orthopaedics may be most well-known for their shoulder, knee, and hip replacement devices.
The History of Stryker
Stryker was founded by Orthopedic Surgeon, Dr. Homer Stryker in 1941 in Kalamazoo, Michigan. Before founding Stryker, Dr. Stryker spent eight years in general practice but did not enter the field of orthopedics until he was 45 years of age but had discovered a number of medical products in use were not as effective as he would like them to be.
Dr. Stryker began his company by inventing his first product while still completing his orthopaedic study, the Wedge Turning 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 started with a patent on an 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
- CoAlighn Innovations
- Berchtold Holding
- Small Bone Innovations
- Sage Products
- Physio-control International
- Entellus Medical
The company is now the largest manufacturer of orthopedics products but holds a significant place in the medical device market as a whole.
Stryker Orthopaedics Implants Recalls and Lawsuits
Today, Stryker controls about one-quarter of the knee and hip replacement market and more than 16 percent of worldwide orthopedics. 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 Orthopaedic’s 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 products 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 that were released from the implants irritated nearby tissues and entered bloodstreams, resulting in device failure and severe health effects to patients. In July 2012, Stryker Orthopaedics pulled the products from the market because of “fretting and corrosion.
Over 3,400 Stryker hip ABG and Rejuvenate lawsuits were filed resulting in settlements of $1.43 billion in 2014, expanded to estimated $2 billion but hundreds of lawsuits may still be pending.
Following the ABG II and Rejuvenate lawsuits, Stryker is now facing nearly 3,000 lawsuits filed for the LFIT Metal V40 femoral head hip implant which 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 has also been recalled.
Stryker Knee Implant Criminal Penalties
Stryker subsidiary, OtisMed and its CEO was accused of distributing non-FDA approved knee replacement devices. Stryker Orthopaedics’ Total Knee, Scorpio CR, and Scorpio PS components were all either partially or totally recalled.
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 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.