In September 2016, Stryker voluntarily recalled the LFIT Anatomic CoCr V40 femoral head, utilized in the Accolade implants. In July 2012, Stryker voluntarily recalled the Rejuvenate and ABG II Modular Hip System Implants.
This report analyzes the worldwide markets for Orthopedic Prosthetic Implants in US$ Million by the following Segments: Hip Prosthesis, Knee Prosthesis, and Secondary Joint Prosthesis (Shoulder Prosthesis, & Other Secondary Joint Prosthesis). The scope excludes Spinal Implants. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 50 companies including many key and niche players such as -
Amplitude Surgical
B. Braun Melsungen AG
Baumer S.A
ConforMIS, Inc.
Corin Group PLC
Additionally, there has been a global settlement involving the Stryker Rejuvenate and ABG II Modular Hip Systems. In 2014, Stryker agreed to a global settlement program (estimated at $1.4 billion) for those who had a recalled Rejuvenate or ABG II implant and who had revision surgery prior to November 3, 2014. The minimum award of $300,000 to most victims is said to be the largest ever in failed hip replacement litigation and comes with few reductions. Qualified victims are also entitled to potential future compensation, even if their case is settled. This global settlement does not prevent individuals with recalled Stryker hip implants from pursuing their own litigation if they do not wish to settle or if they have not yet had a revision surgery.
The lateral approach requires detachment of part of the abductor muscles from the anterior aspect of the proximal femur. These must be reattached upon completion. In both cases, these soft tissue structures must heal to the proximal femur. This can take several weeks or months. During this time, post-operative body positioning can lead to stress at the repair site. If the repair fails, the prosthetic hip joint can become unstable or dislocate. To protect against this, a set of key rules are taught to the patient after surgery. These guidelines, called antidislocation precautions, prevent patients from stressing their soft tissue repair sites by teaching allowable hip and trunk positions. For example, hip flexion coupled with hip internal rotation can stress a posterior soft tissue repair. Therefore, posterior precautions recommend against deep hip flexion and hip internal rotation post-operatively.
Stryker Corp. agreed to pay more than $1 billion to resolve lawsuits over thousands of hip implants recalled in 2012 after patients complained of pain, swelling and metal debris from the devices. Stryker will pay a base amount of $300,000 per case to patients who had the devices surgically removed, Kim Catullo, one of the company’s lawyers, told a New Jersey judge yesterday. The device maker faces more than 4,000 suits consolidated in New Jersey state court and federal court in Minnesota. To read more, click
In addition, there were some highly publicized recalls of metal-on-metal implants because they were shown to require revision surgery (replacement of the replacement) at a higher rate than standard hip replacement implants. As a result of this, metal-on-metal implants have gone from being a very popular type of implant to a very rarely used type of implant.
All of this typically leads to a quicker return to the patient’s desired activities, such as ambulation without assistive devices, driving, and certain sporting activities. The disadvantage of the anterior approach total hip replacement is the added technical difficulty and learning curve. For example, patients with a high body mass index or severe deformity may not be candidates for this procedure. Also, no hip replacement surgery is free of complications. As is true with traditional hip replacement surgery, dislocation, limb length inequality, periprosthetic fractures and other complications can occur.