Stryker Hip Replacement Side Effects
Stryker is one of the largest medical and orthopedic manufacturers in the world. Hundreds of Stryker products are experiencing success on the market. However, in 2012, the company recalled two faulty hip implant systems. The Stryker Rejuvenate and ABG II Modular-Neck hip stems can cause serious injuries. A number of patients are experiencing severe Stryker side effects due to the design of the implants.
Are you suffering side effects because of a dangerous or defective Stryker product? If so, you may be able to file a personal injury claim.
Behind the Stryker Corporation
The Stryker Corporation is one of the largest medical device manufacturers in the world. The company works out of Michigan with operations in over 100 countries. Stryker sells more than $9 billion in products every day. The company faces multiple lawsuits regarding the Stryker Rejuvenate Modular and ABG II Modular-Neck Hip systems.
Stryker Hip Issues Make the News
The Stryker Rejuvenate Modular-Neck Stem and the ABG Modular-Neck Stem hip replacement devices were approved by the Food and Drug Administration (FDA) in 2008 and 2009. The devices were made to be longer lasting and were marketed for a “younger” patient with an active lifestyle.
Part of the design was the lack of a Metal on Metal (MoM) construction, common in many other devices. The lack of all metal features was meant to reduce the chances of metal grating on metal, causing the release of debris. Unfortunately, even though the Stryker products were made to reduce potential side effects, the devices have resulted in a number of “Adverse Local Tissue Reaction” (ALTR). Many of these products are resulting in serious injury and requiring revision surgery.
Stryker issued two “Urgent Field Safety” notices and a report to physicians and surgeons about the proper implantation technique and acknowledging the potential risk of
- metal ion generation
- metallic debris release caused by neck joint corrosion
FDA Reports and Responses for Defective Stryker Hips
By mid-2012, numerous reports were filed with the FDA. The Canadian health authority also recalled the devices. Stryker then voluntarily recalled both of the devices and stopped making these in all global facilities and in August of 2012, the company finally urged physicians and surgeons to contact patients regarding the recalls and potential for risk. Patients were encouraged to contact the company.
Faulty Stryker Hip Design
The side effects caused by Stryker Rejuvenate and ABG II hip systems are caused by a faulty design. Many hip implant systems feature a one-piece stem and neck built to fit patients. This is referred to as a “monoblock” design. However, the Stryker Rejuvenate and ABG II systems should minimize bone stress and maximize stability.
Even though the devices are not typical “metal-on-metal” (MoM), the device necks are constructed of cobalt and chromium and the neck stems are coated with titanium. The metal compositions are intended to be corrosion-resistant, but the junction or joint where the two metals meet, allows the metals to grate on one another, releasing toxic metal ions and debris.
Like most other hip replacement products, Stryker hip replacement products were approved under the 510(k) Premarket Notification Process rather than the more stringent medical device approval process.. This is an exemption allowed for medical devices that are allegedly enough like other devices on the market. If approved, the manufacturer will be able to avoid costly clinical testing. Consequently, the Stryker devices were not implanted in human patients prior to use in the public.
Using the 510(k) process forces the device manufacturer, the medical community, and the public to rely on post-market information to identify dangerous issues. By the time adverse event reports emerged, many patients had already been seriously injured.
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 releases 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
In most patients, revision and reconstructive surgery is significantly more painful than the original hip replacement procedure. It may require much longer recovery periods.
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 Rejuvenate and ABG II 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.
An unusually high number of serious adverse events are being reported to the FDA regarding the Stryker products prompted the company to issue urgent notices and a report to physicians and encouraging physicians to notify patients.
Other side effects
Less severe adverse events may be caused that are usually not medically dangerous, but may impact the patient’s quality of life and ability to perform normal activities. These include 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 or difficulty moving due to pain
- Hip dislocation
Stryker Hip Lawsuits
Stryker faces a number of lawsuits over the Rejuvenate and ABG II systems due to problems caused by metal corrosion and fritting. Most of these patients have required revision surgeries, including one patient in Oregon who underwent two additional revision surgeries on each hip for a total of six surgeries.
Up to 4000 lawsuits have already been filed in federal, state, and local courts regarding Stryker injuries. More than 1700 federal cases have been consolidated into multidistrict litigation (mdl) in Minnesota; several hundred are at the state level in the state of New Jersey. Up to 100 of the Stryker lawsuits have been settled, but many more remain and many more are expected.
Plaintiff’s attorneys have claimed that Stryker designed faulty devices, failed to adequately test them in humans before marketing, failed to warn the public and medical community, and concealed information about the risks of adverse events caused by the devices.
One lawsuit is currently accepting settlement claims in early 2017 for those who have been injured by Stryker’s modular necks. Approximately 20,000 individuals were implanted with the defective medical devices, according to Stryker. They are aiming to close out the majority of legal claims in 2017, but many cases still remain.