Michigan-based Stryker Corp., widely viewed as the largest manufacturer of medical equipment and orthopedic devices, has a duty to properly design its products and warn the public about any risks.
Although the FDA does not require premarket testing of hip implant devices, manufacturers are obligated to design and sell safe products to the public.
Manufacturers, including Stryker, are responsible for warning patients of any risks or dangers associated with their devices.
When a patient suffers significant complications or injuries due to a defective Stryker hip device, it may warrant legal action. Stryker can be held liable for the injuries suffered by the patient.
Stryker hip implant devices, specifically the Rejuvenate and ABG II, received FDA 510(k) approval in 2008. Subsequently, the devices were recalled in 2012.
Many patients who have had a Stryker Orthopaedics hip device implanted have suffered from serious complications, including:
- Fretting and corrosion
- Severe pain in the hip area
- Fluid collection in the hip area
- Avascular necrosis
- Periprosthetic osteolysis
- Metallosis (metal poisoning)
- Systemic injuries such as headaches, tinnitus, etc.
Patients who received a Rejuvenate, ABG II, Accolate TMZF, LFIT Anatomic CoCr V40 femoral heads, or other Stryker implants may choose to pursue litigation to recover damages.
The devices can cause serious side effects, including loosening of the implant and the release of toxic metals into patients — complications that are leading to a number of lawsuits against Stryker. Contact a Stryker lawyer if you have suffered any of these side effects.
ABG II Modular-Neck Stem Hip Replacement Device
The ABG II Modular-Neck Stem, manufactured by Stryker Orthopaedics, is a metal-on-metal joint replacement system that is used as part of Stryker’s hip implant systems.
The ABG II system was designed to be customizable to each patient’s needs. It was also advertised as being longer-lasting and having an increased range of motion.
However, the metal-on-metal components of the ABG II Modular-Neck Stem caused serious complications for many patients. The ABG II Modular-Neck Stem System was recalled by Stryker due to the potential for serious complications. These complications include:
- Fretting and corrosion
- Tissue damage
Corrosion in the ABG II system occurred because the chromium-cobalt neck rubbed against the titanium coating on the stem. This friction released metal particles into the body and, in some cases, caused metal poisoning or metallosis.
Stryker warned patients and surgeons that post-market data revealed the ABG II had an increased rate of Adverse Local Tissue Reaction (ALTR), meaning complications caused by inflammation in the tissue in and around the implant.
Other complications of hip replacements include infection, avascular necrosis, and osteolysis. You should discuss any side effects from your Stryker implant with your attorney.
Stryker Recalls ABG II Neck-Hip Stems
Similar to Stryker’s Rejuvenate Modular hip implant device, the neck components of the ABG II are made of chromium and cobalt, and the stems are coated with titanium.
When these parts wear against each other where the neck meets the stem, they can shed metallic debris into the body and lead to complications.
Stryker warned that post-market data revealed that the ABG II had an increased rate in Adverse Local Tissue Reaction (ALTR) – meaning complications arising from inflammation in the tissue in and around the implant.
“Metal ions in surrounding tissues can result in inflammation leading to an immunological response including metallosis (metal poisoning), necrosis (tissue and bone death) and pain requiring revision surgery,” the hip implant manufacturer said in a released statement.
LFIT Anatomic V40 Femoral Head Hip Replacement Device
The LFIT Anatomic V40 Femoral Head, manufactured by Stryker Orthopaedics, is a metalhead that is placed onto a femoral neck in a total hip replacement procedure.
The LFIT Anatomic Femoral Heads were designed to offer surgeons the flexibility to better match patient anatomy and restore natural movement. However, when the metal femoral head is placed on a metal femoral neck, which is usually the case, creates the complications of a metal-on-metal device.
When the two metal components move against each other, the friction can release metal particles into the body, leading to metal poisoning or metallosis. In the case of the LFIT Anatomic V40 Femoral Head, the corrosion can be so severe as to cause taper lock failure. The taper lock is the part of the implant that connects the femoral head to the femoral neck.
Taper lock failure can lead to many other dangerous complications in patients. The LFIT Anatomic V40 Femoral Head was recalled by Stryker due to the high rates of taper lock failure. According to multiple reports, the cobalt-chromium LFIT V40 heads corrode severely to the point that the head separates from the femoral stem, a condition called “spontaneous dissociation,” or taper lock failure.
This condition requires immediate surgery to remove both the head and the femoral stem. Other complications from taper lock failure include:
- Device loosening or fracture
- Necrosis of surrounding tissue
- Loss of mobility
- Adverse local tissue reaction
- Joint instability
- Broken bones around the device
- Leg length discrepancy
- Revision surgery
Stryker Recalls Anatomic CoCr V40 Femoral Heads
Stryker notified surgeons in August 2016 that it voluntarily recalled certain lots and sizes of its LFIT Anatomic COCR V40 Femoral Heads because of serious health risks to patients.
Stryker advised them of a “higher than expected” incidence of taper lock failure for certain sizes of its device. Possible patient complications from taper lock failure include device loosening or fracture, necrosis of surrounding tissue, and metallosis, which could require additional surgery to revise or replace the product.
The LFIT Anatomic CoCr Femoral Heads were designed to offer surgeons the intra-operative flexibility to better match patient anatomy and restore natural movement.
According to multiple reports, the cobalt and chromium heads of the LFIT V40 corrode severely to the point that the head separates from the femoral stem, a condition called “spontaneous dissociation.” It requires immediate surgery to remove both the head or “ball” and the femoral stem.
The taper lock is the part of the implant that connects the femoral head to the femoral neck.
If this occurs, the patient could experience:
- loss of mobility
- adverse local tissue reaction
- joint instability
- broken bones around the components
- leg length discrepancy
- need for revision surgery
This is not the first time Stryker has initiated a recall of hip components with a higher than expected rate of failure, and you should talk to your lawyer about how a recall can impact your lawsuit.
Other Stryker Recalls
In 2012, Stryker Orthopaedics voluntarily recalled its Rejuvenate Modular hip implant device due to several studies that proved the device was prone to fretting and corrosion.
Between the years of 2009 and 2012 thousands of patients received these hip implants.
According to Stryker, the modular-heck hip system may result in ALTR (adverse local tissue reactions), as well as possible pain and/or swelling at or around the hip.
Surgeons should consider performing a clinical examination, such as blood work and cross-section imaging on all patients who received a Rejuvenatemodular-neck hip stem regardless of whether a patient is experiencing pain or swelling.
Stryker also suggests surgeons consider repeat follow-up examinations, such as blood work and cross-section imaging, even in the presence of normal initial findings.
Stryker also recalled its Accolade TMZF Plus Hip Stem in 2009, 2011, and in 2013 for packaging and manufacturing errors.
Accolade is made of Stryker’s proprietary titanium alloy, TMZF, and may corrode and fret when used with cobalt-chromium femoral heads.
The stem has a PureFix HA coating, designed to help the bone grow around the implant for a better fit. The controversial hip stem causes many of the same problems as the other two stems.
Work with a Stryker Attorney
The following criteria must be met to be eligible to file a hip implant lawsuit:
- Patient implanted with the Stryker Rejuvenate or ABG II modular hip stem
- Had implant done after January 1, 2007
- Revision surgery and non-revision surgery cases are accepted
Our Stryker lawyers can help you through each step of the case process to demand full and fair compensation.