Stryker Hip Replacement Side Effects
Stryker is one of the largest medical and orthopedic manufacturers in the world. Hundreds of Stryker products have found success. However, in 2012, the company recalled two faulty hip implant systems. The Stryker Rejuvenate and ABG II Modular-Neck hip stems were linked to a number of adverse reports and patient injuries. A number of patients experienced severe Stryker side effects due to the design of the implants.
The Stryker Corporation is one of the largest medical and orthopedic device manufacturers in the world. The company is based in Michigan with operations in over 100 countries. Stryker has estimated yearly sales of over $9 billion. Stryker has manufactured hundreds of medical devices and joint replacement products, most of which have been successful; however some of the hip replacement devices have caused serious adverse events resulting in injury to hundreds of patients. The company faces multiple lawsuits regarding the Stryker Rejuvenate Modular and ABG II Modular-Neck Hip systems.
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 designed to be longer lasting and were marketed for a “younger” demographic for a 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 components was intended to reduce the probability of metal grating on metal, causing the release of metallic debris. Unfortunately, even though the Stryker products were designed to reduce the potential for side effects, the devices have resulted in a number of “Adverse Local Tissue Reaction” (ALTR) resulting in serious injury and requiring revision surgery.
Stryker issued two “Urgent Field Safety” notices and a report to physicians and surgeons delineating the proper implantation technique and acknowledging the potential risk of metallosis, metal ion generation, and metallic debris release caused by neck joint corrosion.
By mid-2012, The FDA had received numerous serious adverse event reports stating ALTR and the Canadian health authority recalled the Stryker devices. Stryker subsequently voluntarily recalled both of the devices and discontinued manufacture 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 but many had already experiences severe adverse events.
Faulty Stryker Hip Design
The side effects caused by Stryker Rejuvenate and ABG II hip systems are primarily 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 were designed to 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 were 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 claimed to be enough like other devices on the market so that 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 began to appear, many patients had already been seriously injured.
Serious Adverse Events and Metal Corrosion
Hip implants of all types may cause serious side effects but 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 surrounding 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 and may require much longer recovery periods.
Stryker implants may 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 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. The devices were recalled by the Canadian health authority in Canada and were voluntarily recalled by Stryker in 2012 but many patients had already experienced side effects and were not notified about the problems.
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 due to Stryker implants may 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 has been required to undergo 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.