Stryker Hip Replacements
The Stryker Orthopaedics manufactures medical devices for joint and bone replacement procedures as well as other products for the surgical profession. They hold over 5,300 patents for products ranging from hip replacement and bone prosthetic devices to blood clot removal devices and data analytic programs. Stryker operates in over 100 countries around the globe and has yearly sales of over $9 billion.
Some of Stryker’s best-selling products have included their hip replacement devices used for total or partial hip replacement surgeries. Several of these devices have come under fire and required recalls to mitigate a risk for early failure, serious injury and requirement for revision surgery.
Styker Hip Implant Models
Though Stryker makes a number of hip implant products, the devices which have caused the highest concerns over severe or serious side effects include:
- Stryker Rejuvenate Modular Neck Stem
- Stryker ABG II Modular Neck Stem
- Stryker LFIT V40 Femoral Head
Stryker Rejuvenate and ABG-II Modular Neck Stem Devices
The Stryker Rejuvenate modular-neck stem for use in hip replacement surgery was approved by the U.S. Food and Drug Administration (FDA) in June of 2008 and the Stryker ABG-II modular-neck stem device was approved in November of 2009. Both products were marketed for “younger” patients and advertised as “high performance” devices which were intended to be more durable and longer-lasting. The Rejuvenate system included 6 stems and 16 necks, while the ABG-II system had 8 right stems, 8 left stems and 10 necks for a variety of configurations.
The devices were designed to more closely model the biomechanics and anatomy of the human hip and to provide enhanced stability. The were both also engineered as a modular unit to make implantation easier for the physician who could choose components to best fit a particular patient. The Rejuvenate and ABG-II systems were not designed as strictly metal-on-metal implants which had already been shown to be problematic but were supposed to resist metal fatigue and corrosion. Unfortunately, patients were still exposed to significant risks caused by the devices and their construction of titanium, zirconium, molybdenum and iron.
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 LFIT V40 Femoral Head
The Stryker LFIT V40 Femoral Head is a part of Stryker’s modular system which is used in replacement surgery to replace the top portion of the large leg bone, or femur. It was approved in 2001 and was designed to be used as a component with other Stryker components. The LFIT V40 device is constructed of the metals cobalt and chromium which were believed to be exceedingly durable and quite safe. The design was intended to match patient anatomy and mimic natural biomechanics to provide increased range of motion and reduce dislocation events.
Unfortunately, in 2016, Stryker was forced to recall multiple model numbers of the LFIT V40 (CoCr) Femoral Head devices due to a high risk of taper lock failure. Failure of the femoral head could lead to hip dislocation, unseating of the head from the leg bone, fracture of the hip and/or leg, increased metallic debris and other complications. In 2017, the LFIT recall was expanded to include additional devices from the same line.
Stryker Hip Recall
The Stryker Corp. is a medical technology company based in Kalamazoo, Michigan which manufactures a number of joint and bone replacement medical devices. Many of the Stryker medical devices have been successful but some of their hip replacement products have caused serious injury to patients. Because of these injuries and potential threat of additional injuries, over the last several years, the company has been forced to issue multiple recalls of several types of Stryker hip implants.
Stryker hip recalls have previously been issued for:
- Stryker Rejuvenate Modular systems
- Stryker Accolade TMZF
- Stryker ABG II Modular systems
- Stryker LFIT V40 Femoral Head
Stryker Rejuvenate Modular and ABG II Hip Recall
The Stryker Rejuvenate Modular-Neck Stem hip replacement device was approved by the Food and Drug Administration (FDA) in 2008. This was followed in 2009 by the approval of the ABG Modular-Neck Stem in 2009. The devices were marketed for “younger” patients and were designed to closely mimic the anatomy and function of the human body.
Unlike other devices, these products were manufactured as “modular” units to make implantation easier for orthopedic surgeons and to allow for better product selection. They were intended to resist corrosion and metal fatigue – to provide a longer lasting implant without metal-on-metal construction which had already caused a number of injuries. Despite the attempt at improvement, the Stryker devices were still subject to a number of problems.
In June 2012, Stryker issued two “Urgent Field Safety” notices and published a report for physicians and surgeons regarding the proper implantation technique. The company acknowledged that the devices may be subject to potential failure due to metallosis, excessive metal debris, and ion shedding caused by corrosion at the neck junction. Despite the warning to physicians, no public notification was given.
By July of 2012, the Canadian health authority had recalled the devices and the FDA had received more than 60 serious adverse event reports regarding metal toxicity such as “Adverse Local Tissue Reaction” (ALTR), most of which required surgery. Post-market surveillance showed a higher than normal failure rate of both the Rejuvenate and ABG II hip stems and also revealed that patients experienced a higher than normal rate of side effects caused by corrosion and fretting of the components. Based on this data, Stryker issued a voluntary recall for both the Rejuvenate and ABG devices and halted global production and sales at the same time.
In August of 2012, Stryker finally urged physicians to inform their patients of the recalls and to encourage them to contact the company, but many patients had already experienced serious injury such as bone death and metal toxicity, requiring revision surgeries. Neither the Rejuvenate nor the ABG II were returned to the market after recalls.
Stryker LFIT V40 Femoral Head Recall
Approved in 2000, Stryker Metal LFIT V40 Femoral Head is one component of a hip implant system which was designed to be used with the Stryker Accolade TMZF and Accolade 2 stems and is now also used with the Stryker Meridian and Citation stems.
An August 2016 “Urgent Medical Device Recall Notification” letter was sent to all surgeons implanting patients with the V40 LFIT device. A high number of reports had been received by the agency indicating that the devices may be subject to disassociation of femoral head from hip stem, fracture of the stem, corrosion of the trunnion, excessive metallic debris and numerous other complications caused by corrosion at the connection between the head and stem (trunnion).
The recall involved a number of lots manufactured before 2011 and included a potential 42,000 units. In May 2018, the recall was expanded to include additional lots manufactured between 2002 and 2011. Recent published studies have shown symptoms and failures of these metal heads may occur, even in lots not covered in the affected Stryker recall.
Stryker had previously manufactured another hip device which was used with the LFIT V40 Femoral heads, the Accolade TMZF which had also resulted in a number of injuries. Three temporary recalls were issued between 2009 and 2013 due to packaging and manufacturing issues but the device remains on the market with ceramic head.
Faulty Stryker Hip Design
The Stryker Rejuvenate and ABG II hip systems and the LFIT V40 Femoral heads are not typical “metal-on-metal” (MoM) but the device necks are constructed of cobalt and chromium. The neck stems are coated with titanium which causes a junction, where the two metals may grate on one another, generating metallic debris around the implant site.
Like many other hip replacement products, the Stryker devices were approved under the 510(k) Premarket Notification Process. This is an exemption allowed for medical devices that are “substantially similar to and not substantially different from” medical devices already on the market. The 510(k) process allows the manufacturer to avoid expensive clinical testing.
The Stryker products were not subject to clinical trials, consequently physicians and patients had to rely on post-market surveillance reports to identify problems and many patients had already been injured, suffered severe side effects or required revision surgeries by the time reports surfaced.
Stryker Hip Implant Side Effects
Stryker Corporation, which manufactures a number of hip implant devices, is one of the largest medical and orthopedic manufacturers in the world. While most of the devices are successful, some of the Stryker hip implants have been responsible for serious medical injuries and resulted in a need for revision surgery due to severe side effects.
Serious Adverse Events and Metal Corrosion
Hip implants of all types may cause serious side effects. However, the Stryker devices have caused a higher than normal occurrence of failure due to corrosion and fritting of the metal which can release metal ions and fragments into surrounding tissue causing severe adverse events such as:
- Metallosis – tissue poisoning due to metal ions and fragments
- Necrosis – tissue and bone death due to metallosis toxicity
- Osteolysis –dissolution of necrotic bone tissue, caused mainly by metal toxicity
- Systemic metal poisoning – body wide inflammation due to metallosis entry into the blood stream
- Pseudotumors – false tumor formation surrounding the joint due to inflammation
- Bone fracture – bones near the joint may weaken and fracture
- Revision Surgery – to replace implant due to pain or severe inflammation
- Reconstructive surgery – due to weakened bone tissue resulting in fractures of femur or pelvis
Stryker implants can cause a systemic inflammatory or immune system reaction from metal poisoning which resulting in symptoms such as rash, fatigue, headache, and infection.
Stryker Revision Surgery
Most patients who experience severe side effects caused by Stryker hip implants must undergo additional surgery or surgeries to remove and replace the implant. Some patients are required to undergo multiple surgeries to repair or reconstruct injured joints, bones, and tissue in addition to the replacement surgery.
Hip revision and reconstructive surgery is often significantly more painful than the original hip replacement procedure and may require much longer recovery periods. Patients who undergo hip revision surgery are exposed to an increased risk of infection and are more likely to need revision surgery in the future.
This may include:
- Revision Surgery – to remove faulty or failing implant and replace with a new implant to eliminate pain and restore function.
- Reconstructive surgery – to repair damage such as broken bones, necrotic tissue, or degraded bones which have occurred due to joint destabilization or injury caused by metallosis or fragmentation.
A Stryker hip revision surgery will be more complex than the original joint replacement surgery. When compared to a first-time hip implant, revision surgery may subject the patient to more pain, additional infection risk and will require a longer recovery period. Some patients who undergo revision surgery may require multiple reconstruction surgeries to repair tissue or bone which has been damaged.
In addition, In addition, people who undergo one revision surgery are at a higher risk of requiring future revision surgery. As tissue and bone is destroyed by implant failure, it may be weaker and less able to maintain integrity.
Stryker Hip Revision Surgery Lawsuits
Because of high rates of early failure and serious complications caused by Stryker hip replacement devices, many victims have filed medical injury lawsuits. Hundreds of these lawsuits remain in federal, state and local courts and many more may be expected.
Other Stryker Hip Side Effects
Less severe side effects which are not medically dangerous, may impact the patient’s quality of life and ability to perform normal activities. These include:
- Pain in implant area, groin and abdomen
- Inflammation in implant area, groin and abdomen
- Difficulty in standing or walking due to hip instability
- Loss of muscle mass due to immovable joint
- Difficulty moving due to pain
- Hip dislocation
Even when side effects are not life-threatening, they may still increase the need for revision surgery to remove and replace the implant. Under any conditions, revision surgery will still carry increased risks for pain, infection and disability.
The FDA 510(k) approval process
Normally, the Food and Drug Administration requires that new medical devices undergo the Premarket Approval (PMA) process. Similar to new drug approvals, the PMA requires that a new medical device undergoes clinical testing in human patients according to stringent guidelines and that sufficient valid scientific evidence is presented that provides reasonable assurance that the device is safe and effective for its intended use.
The Stryker hip replacement products which have caused a greater-than-expected number of serious injuries were approved under the FDA 510(k) process. This is a “fast-track” process which allows manufactures to skip clinical testing by claiming that a device is similar to other products which are already on the market.
Because the Stryker products were approved under the 510(k) and not the PMA, Stryker hip replacement devices were never tested in humans. The failure to conduct suitable clinical testing may have been responsible for many of the injuries which could have been prevented if problems had been identified.
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.
Stryker Hip Settlements
The first lawsuits regarding Stryker’s faulty Rejuvenate and ABG II hip implants were filed in August of 2012 in federal court. Those initial lawsuits and hundreds that followed were consolidated into multidistrict litigation (MDL) in the U.S. District Court for the District of Minnesota. Hundreds of lawsuits filed in New Jersey courts were consolidated into multi-county litigation and many more have been filed in other state and local courts.
The Minnesota federal Judge, Donovan Frank ordered that attorneys for federal plaintiffs should coordinate with lawyers in the New Jersey cases to avoid duplication of efforts. This order indicates that settlements that happen in federal courts may influence local courts or vice versa.
The first four cases in New Jersey were settled for an undisclosed amount in December of 2013 and an additional eight were settled in March of 2014. In November of 2014, Stryker preemptively offered settlements to litigants in both the federal MDL and New Jersey MCL cases before any of the case trials actually began. The total settlement offering was at $1.43 billion, with each claimant possibly receiving up to $600,000. In offering the settlements before trials began, Stryker hopes to avoid more costly verdicts that have been awarded in other hip device injury trials.
The Stryker Corporation reportedly originally estimated settlements at a lower amount with the expectation to spend $700 million to $1.1 billion but continued filings have driven that number higher. Stryker has also been sued by its malpractice insurance company which has been forced to pay out millions to settle knee replacement lawsuits.
Though many Stryker hip lawsuits may have been settled, additional lawsuits are
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.