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
Many patients who have been injured by a Stryker hip replacement device have filed lawsuits against the company. Some lawsuits have already been settled but thousands more remain in federal, state and local courts and more may be expected. People or loved ones of those who have been harmed by a Stryker Hip Replacement Device should seek legal assistance.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.