Stryker Hip Replacement
Stryker Orthopaedics company manufacturers surgical medical devices including a number of bone and joint replacement devices. Stryker hip replacement devices have been some of the best-selling artificial joint products and have been used in hundreds of thousands of procedures around the world.
Several of Stryker’s hip replacement devices have been problemsome and have required a number of recalls to be issued due to early failures, serious injuries and a high rate of revision surgery for many patients.
Stryker hip replacement products which have been recalled and have been the subject of numerous lawsuits include:
- Stryker ABG-II modular-neck stem
- Stryker LFIT V40 (metal) Femoral head
- Stryker Rejuvenate modular-neck stem
Stryker Hip Replacement FDA Approval
Stryker hip replacement products, like many other hip devices which have caused problems for thousands of patients, were approved under a Food and Drug Administration (FDA) fast-track process. The FDA 510(k) process allows manufacturers to forgo clinical testing in humans by claims that a device is similar to other products already on the market. The Stryker products approved under the 510(k) pathway were likely never tested in research patients before being offered to the public.
Stryker’s LFIT v40 Femoral Head was approved as part of a modular hip system in 2001. The Rejuvenate modular-neck stem device for use in hip replacement was approved by the U.S. Food and Drug Administration (FDA) in 2008 and the ABG-II modular-neck stem device was approved in 2009. All three products were metal-on-plastic devices to be marketed for “younger” and more active patients. They were marketed as high performance, longer-lasting devices which were more durable.
Stryker Rejuvenate, ABG and LFIT v40 systems included multiple sizes of stems and necks for a variety of configurations which would fit a greater number of patient body types. They were intended to better model the anatomy and biomechanics of the human hip joint to provide better mobility and stability and were created as modular units which were easier to implant, reducing the difficulty of the surgical procedure.
Stryker Metal on Plastic (MoP) Construction
Unlike many hip implant devices, the Stryker Rejuvenate , ABG-II and LFIT v40 systems were not designed as metal-on-metal (Mom) implants already shown to be problematic. They were intended to resist metal fatigue and corrosion, while avoiding the problems of MoM construction. Unfortunately, patients were still exposed to significant risks caused by the devices which used metal alloys containing titanium, zirconium, molybdenum and iron or cobalt and chromium.
Rejuvenate and ABG-II devices were recalled in 2012 due to a high number of reports of metallosis and other side effects which resulted in a need for hip revision surgery. The Stryker LFIT V40 Femoral Head was recalled in 2016 with more versions added in 20107 and 2018.
Both the Rejuvenate and ABG-II hip replacement devices were recalled in 2012 and discontinued within three years of introduction due to an abnormally high number of cases of metallosis and other side effects were shown to be caused by corrosion and fritting of the modular-neck stems.
Stryker Hip Replacement Side Effects
Stryker hip replacement devices have caused serious adverse events and severe side effects in thousands of patients. Many of these side effects are a result of metal fragments and ions which are shed from the implant into surrounding tissue.
Severe side effects include:
- Metallosis – poisoning of the local tissue by metal fragments which have been released through grating of the implant surfaces on one another
- Pseudotumors – formation of “false” tumors which are large collections of solid or semi-solid mass around the implant.
- Necrosis – tissue death in surrounding areas, likely due to metallosis toxicity
- Osteolysis – dissolution of bone tissue from contact with metal fragments and toxicity
- Systemic metallosis – inflammatory response with flu-like symptoms which may result in neurological and other system damage
Revision surgery is usually required to remove and replace a failed implant. Many patients who require revision surgery also require one or more reconstructive surgeries, each of which will pose serious complications and require significant recovery time.
Stryker Hip Replacement Lawsuits
More than 20,000 people received Stryker implants from the company’s ABGII and Rejuvenate lines. Now, in addition to those two particular models, those with implants from the company’s Accolade, Citation, and Meridian lines of products might also be eligible for compensation.
If you’re the recipient of any of the following devices, you could be eligible for financial compensation:
- ABG II
- Accolade TMZF
- Citation TMZF
- Meridian TMZF
- LFIT Anatomic CoCr V40 femoral head
According to the lawsuits filed against Stryker, the company knew about or should have known about the problems linked to the hip implant devices. Instead, they manufactured, marketed, and distributed the devices calling them safe and effective. The company is accused of failing to take reasonable care for the safety and well-being of patients and to adequately test the device. Stryker’s marketing was also called “false and misleading.”
The 2014 settlement cost Stryker more than $1.4 billion with individual patients receiving at least $300,000 and up to $600,000 for their injuries and complications. Only people who’d undergone implantation in the United States or in a United States military hospital qualified for compensation, and they had to have experienced complications that included:
- Evidence of metallosis
- Abnormal diagnostic scan
- Evidence of tissue damage
Older patients, patients unable to receive revision surgery, and patients who died before enrollment in the settlement received less compensation. Awards could also be greater based on specific details of injuries.
In 2016, Stryker expanded the terms of the settlement and increased the number of hip implant recipients who received compensation due to injuries caused by their ABGII and Rejuvenate hip implants that required revision surgery.
Despite the settlements that have already occurred, recipients of Stryker hip implants could still be eligible for financial compensation. Every case is different. If you or a loved one experienced complications after hip replacement surgery, contact an experienced attorney to discuss your case.
If you or a loved one was injured by a Stryker hip implant, you could be eligible for financial compensation. Thousands of recipients of these and other hip replacement devices have already been awarded money for their medical costs associated with the need for follow-up surgeries and for pain and suffering.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.