Stryker Corporation is a Michigan-based medical technologies firm known for its extensive line of total hip and knee replacement systems. In 2012, Stryker recalled two of its most popular hip replacement products, Rejuvenate® and ABG II®, due to flaws in the metal-on-metal construction.
Stryker designed these hip implants to appeal to younger hip replacement patients and touted them as offering enhanced joint stability and a greater range of motion compared to older hip replacement systems. Unfortunately, this proved to not be the case. Rather than offering improved mobility that allowed patients to maintain an active lifestyle, the Rejuvenate and ABG II implants left many hip replacement patients in excruciating pain and with even less mobility than they had before the surgery.
As a result, some patients were even forced to undergo revision or reconstructive surgeries to remove the faulty implant and repair the damage it caused. These procedures are considered more painful and invasive than initial hip replacement surgeries and, because they're usually required in older people, expose patients to an increased risk of surgical complications such as infection.
Stryker Hip Implant Development and Recalls
Stryker Rejuvenate and ABG II hip replacement systems went from approval to recall in just five and four years, respectively. Consider the following timeline:
- 2008: The U.S. Food and Drug Administration (FDA) approves Stryker's Rejuvenate modular-neck hip stem, touted as being able to recreate patients' individual anatomy and biomechanics.
- 2009: Stryker's Rejuvenate Modular Primary Hip System enters the U.S. market, supported by a robust marketing and advertising campaign.
- 2009: The FDA approves Stryker's "high performance" ABG-II modular-neck stem, which was designed resist corrosion and was subsequently marketed to a younger patient demographic.
- 2010: An "urgent field safety notice" Stryker issued to surgeons discussed safe implantation techniques and identified a less than 1-percent failure rate due to metal particles released by fretting at the neck and stem morse taper junction. However, Stryker did not inform patients of this potential problem.
- 2012: Stryker issues an "urgent field safety notice" to U.S. surgeons and hospitals, alerting them to potential hazards associated with their Rejuvenate and ABG II hip replacement systems. According to the alert, the fretting at the modular neck junctions could result in excessive metal debris and increased metal ion generation in the tissues surrounding the implant.
- 2012: A Canadian regulatory agency recalls the Stryker Rejuvenate.
- 2012: The FDA begins receiving reports of Stryker hip implant-related metal toxicity that required revision surgery.
- 2012: Stryker voluntarily recalls the Rejuvenate and ABG II modular neck systems in the U.S. and stops producing them.
- 2012: Patients are notified of the recalls, and are urged to contact Stryker and their doctors.
FDA Approval Process for Recalled Stryker Implants
Some experts claim the problems with Stryker's Rejuvenate and ABG II happened in part because they were approved by the FDA before thorough tested. Because they were deemed similar to implants that were currently on the market, the FDA didn't require the Rejuvenate and ABG II hip implant systems to undergo clinical trial prior to approval.
Did You Suffer Injuries From a Recalled Stryker Implant?
Stryker Rejuvenate and ABG II hip replacement systems are linked to a number of adverse effects, including metal poisoning (called metallosis) caused by the buildup of tiny metal shavings in the tissues surrounding the implant. Patients also report incidents of dislocations, infection, bone damage or bone death, joint instability, excruciating pain, and reduced mobility.
Stryker has faced thousands of lawsuits from patients who were injured by their recalled hip implant systems. If you had a serious adverse reaction to Stryker Rejuvenate and ABG II hip implants, McGartland Law's skilled personal injury attorneys can help you pursue compensation for your injuries. Contact our firm today to schedule a free consultation to discuss your case with a legal professional.