Stryker offers what are supposed to be replacement solutions for implants of the hip, shoulder, and knees. Working along with Mako Robotic-Arm Assisted Technology and Performance Solutions, they provide the market with consultative services of the orthopedic line. However, there have been many patients who have suffered injury because of their products. Read on to understand more about the product and issues.
What Stryker Offers
Stryker’s Sports Medicine company offers a wide range of innovative implants for the sports medicine industry. Their focus is to provide minimally invasive along with open approaches to repair or replace small joints, hips, knees, and shoulders. Their goal is to allow athletes, and other patients to heal and excel both operationally and clinically.
Why You Would Need a Hip Replacement
When a person suffers from pain in their hips, it makes day-to-day living difficult. The pain includes stiffness, soreness, and inflammation, making it challenging to perform activities such as moving and walking. How do you know when the pain means you need a hip replacement?
Before a person decides on hip replacement, they should try more conservative treatments first. Anti-inflammatory medicines such as ibuprofen can soothe hip pain while walking aids such as walkers and crutches can take the pressure off the hip to lessen pain. However, when exercise, physical therapy, and pain relievers are not improving the hip, it might be time to discuss with your doctor, the need to have a hip replacement.
- Conservative Treatments
Exercise is one way to help alleviate hip pain. Speak with your doctor to learn about activities that can strengthen the muscles surrounding your hips and reduce your pain. If your pain is mild to moderate, some exercises can help improve how your hips feel and possibly postpone the need for surgery.
- Physical Therapy
A physical therapist will know different approaches to lessening pain by teaching better posture or ‘form’ when performing daily activities. They can even show you better ways to get up and out of a chair. There are assistive tools to help people walk, such as walkers and canes, and a physical therapist can show you how to correctly use these tools for the best impact on your hips. The therapist may also have recommendations on how you walk and how to implement strengthening exercises depending on your joint functions, disease progress, and your anatomy.
There are some over-the-counter (OVC) medications your doctor can recommend which are anti-inflammatory to help reduce the pain and swelling in the hip joint. NSAIDs (non-steroidal anti-inflammatory drugs) such as steroid medications, ibuprofen, or corticosteroid injections are also helpful. These medications should be used on your doctor’s advice and monitored.
If the non-surgical treatments do not provide sufficient pain relief, you will want to discuss your options of having the hip or hips replaced.
There have been hip replacements performed for more than 125 years, and the procedure is now completed more than 300,000 times each year in just the United States. The arthritic ends of the hip bone along with the damaged cartilage are removed and replaced with a prosthetic implant, so the hip is healthy again.
When a total hip is replaced, hip arthroplasty, the surgeon removes the arthritic ball end at the top of the thigh bone and places a metal component, or stem, into the bone. The hip socket is then replaced with an acetabular cup that has been lined with polyethylene plastic. There are options to this procedure like the robotic-assisted surgery and the muscle-sparing approach that can minimize the impact of surgery.
The Stryker Hip
Stryker’s Rejuvenate and ABG II hip systems received FDA (Federal Drug Administration) clearance. The formula submitted for the hip replacement allowed the manufacturers to bypass clinical trials if their device is similar to a device already approved by the administration. Due to this allowance, the Stryker Hip received approval as it resembled other metal-on-metal prosthetic hip devices.
After the Stryker Hip was placed in patients, numerous reports started coming in regarding serious medical complications surrounding the implant, the FDA investigated the device and was forced to issue a voluntary recall of the product in 2012.
The Stryker Company issued an announcement where they would voluntarily remove Rejuvenate and ABG II modular-neck-stems and halt global distributions of the products. If anyone had received a defective Stryker hip replacement system and had experienced any illness or injuries including fractures, corrosion, metal-poisoning, fretting, or any other medical conditions that required surgical intervention they were advised to contact an attorney.
Lawsuits Involving the Stryker Hip
Lawsuits against the Stryker Hip alleged a number of damages and losses. The most common of these was that the Stryker Hip tends to corrode, fray, and fail prematurely. These defects required the need for a new replacement or reconstruction surgeries a lot earlier than should have been expected. There were additional allegations with these complaints:
- Because the ABG II and Rejuvenate can corrode and deteriorate, they cause severe metal toxicity in patients
- The Stryker systems that were recalled contain serious manufacturing and design flaws which can cause severe and permanent damage to patients
- Stryker reportedly knew, or they should have known, that the systems were inherently dangerous
- Stryker did not properly test the device
- Stryker was negligent when they did not warn doctors and patients of the dangers the device was capable of, including metal poisoning once the systems frayed and the metal shards were deposited in surrounding blood, bone, and tissues. This poisoning leads to severe side effects and in some cases, permanent danger.
- Stryker marketed the product aggressively, and willfully misled the public when they did not inform consumers about the dangers.
Other Health Conditions Linked to Stryker Hip Replacements
The Stryker hip systems were constructed with a metal neck that was placed inside a metal stem. Because the metal corroded and friction was created between the stem and the neckpiece, research and FDA follow-up investigations confirmed the device generated microscopic metal debris that got absorbed into surrounding tissue and bone. This absorption can cause a deterioration in the joint’s support system. When the joint’s support system deteriorates, it loosens the entire hip prosthetic and results in premature failure.
The fine metal shards also enter the patient's bloodstream. These shards can lead to several adverse reactions and other toxic reactions which the FDA has identified as:
- Weight gain, thyroid damage, neck discomfort, phantom chills, and fatigue
- Skin Rashes
- Cardiomyopathy which is a condition that enlarges and weakens the heart muscle
- Impaired kidney functions
- Impairment of cognitive function, depression, or other psychological issues
- Impaired vision or hearing
To reverse the effects of a defective Stryker hip implant is to remove and replace the device surgically. There are risks with this procedure as well:
- Bone fractures
- Difference in leg lengths
- Increased risk of hip dislocation
- Additional rehabilitation
Why is There Pain in My Shoulder?
The greatest range of motion for your joints is found in the shoulder. The ball-and-socket joint is supported with large muscles and other soft tissues. The muscles and tissues are what keep the ball-and-socket joint in place and allow their movements. This area is often called the rotator cuff and gives the shoulder joint support and stability.
When this part of your body is working well, you seldom think about your upper arm and the parts that make it work smoothly. The upper arm consists of your humerus, scapula or shoulder blade, the clavicle or collarbone, and all the soft tissue to help them work together. When they don’t work well together, the pain can be excruciating.
The shoulder joint contributes to a lot of your body’s movements, and it is put to the test every day. Pain in the shoulder can be due to overuse, chronic swelling, inflammation, or an injury.
- OA (osteoarthritis)
OA is a common form of arthritis connected with shoulder pain. It can be caused by the wear-and-tear the shoulder suffers over time, or it can develop years after an injury, such as a dislocation.
- Cuff-Tear Arthropathy
Cuff-Tear Arthropathy often happens after a significant injury to the rotator cuff or muscles and can lead to changes in the surrounding tissue and bone. These changes limit the movement of your arm and make it feel weaker.
- AVN (Avascular Necrosis)
AVN happens when a healthy blood supply cannot reach the ends of the bone. The bone needs this blood supply to remain healthy. When there is no blood flow, the bony matter dies, and the ends of the bones become weak, often resulting in collapse. When the bone collapse, it can damage the surrounding tissue and cartilage. AVN affects the shoulder joint usually at the top end of the humerus.
Each doctor has their own approach to treating shoulder pain, but most follow a similar procedure. They will first try to determine when your pain began and where the pain is located. Learning where your pain is located, your doctor may know right away what is happening to cause the pain. If it is hard to determine from your answers, they may need to perform an x-ray to locate the problem.
It doesn’t always mean you will need surgery because you are suffering from pain. There may be a combination of treatments that could work to reduce or alleviate your pain. Some of those treatments include over-the-counter pain relievers, physical therapy, rest, or putting ice packs on the painful area.
- Lifestyle Changes
R.I.C.E. is an acronym for Rest, Ice, Compression, and Elevation. A doctor might recommend these conservative and practical methods to help joint pain when they have been overused or injured. You can rest to avoid further injury, place ice on the area of pain on and off for 15 minutes at a time. Take an elastic bandage and apply it to the area for compression to reduce swelling and support the shoulder. Keep the shoulder elevated when you rest by propping it up with a pillow or wedge.
- Physical Therapy
A physical therapist can help you lessen pain by showing you better posture or form for daily activities. The therapist may suggest stretches and strengthening exercises, depending on your reason for shoulder pain, joint functions, and anatomy. They can show you how to use assistive devices such as long-handled shoehorns, bath sponges, grabbers, and zipper pulls so you can reach items without stretching out your shoulder muscles or going outside of your current range of motion.
There are over-the-counter medications your doctor can recommend to reduce pain and swelling. NSAIDs (non-steroidal anti-inflammatory drugs) such as steroid medications, ibuprofen, and corticosteroid injections can help. These medications should be monitored by your doctor.
Exhausting all non-surgical treatments with no relief from the pain means shoulder replacement surgery may be required. In a shoulder replacement surgery, the arthritic ends of the bone and the damaged cartilage are replaced with prosthetic implants. These implants are designed to move like a healthy shoulder.
The surgeon replaces the damaged humerus and shoulder socket or glenoid and replaces them with surgical-grade metal and polyethylene components. These parts are called implants, and your doctor may refer to the procedure as an arthroplasty.
There are options to shoulder surgery replacement, depending on the condition of your shoulder. Your doctor could recommend reverse shoulder replacement or a total shoulder replacement to help you relieve the pain and get your range of motion back.
The Stryker Shoulder
In 2016 the Stryker Company issued a warning to orthopedic surgeons using their TSA shoulder replacement system. The warning stated the company was aware the device may fail during surgery, which could compromise the implant’s effectiveness as well as the patient's health.
The TSA Peg Alignment Sound, part of the shoulder implant system, had a high risk of breaking during surgery. This part is what is used in the ReUnion TSA shoulder system to confirm seat height and peg alignment of the TSA before the final implantation.
In response to Stryker’s warning, the FDA also issued a recall notice for the ReUnion TSA Peg Alignment Sound device stated as being defective. This device is manufactured by a subsidiary of Stryker Corporations, the Howmedica Osteonics Corp.
This recall was categorized as a Class 2, which the FDA issues when a product can be responsible for temporary or medically reversible severe health consequences. This classification is the second-most serious recall the FDA can issue.
Complications Arising from the Stryker Shoulder
This recall is not the only one for a Stryker Shoulder Implant. In 2007 there was a recall of its shoulder prosthesis. This prosthesis was the ReUnion Fracture Stem with the Humeral Component, and its recalled stemmed from the plasma spray component that was delamination from the proximal portion of the humeral stem.
The FDA warned patients with defective implants that they were at risk for these side effects:
- Severe tissue reactions
- Joint instability
- Nerve damage
- Severe pain
- Implant failure
Implant Recalls for Stryker Products
Stryker Corporation is the largest orthopedic device company in the world. Their hip, knee, bone, and shoulder products are used across the globe by millions; however, thousands of patients received defective Stryker devices:
- In 2012 the Stryker Rejuvenate and the ABG II modular-neck hip stems were recalled
- In 2013 the Stryker Accolade modular system was recalled
- In 2014 the Stryker Corporation had to settle lawsuits for defective devices which amounted to more than one billion dollars
- The FDA has become aware of the Stryker Scorpio, and Duracon knee implants are not meeting manufacturing standards and have warned Stryker of this issue
When Do You Need a Knee Replacement?
Typically, the reason for a knee replacement is osteoarthritis. This disease prevents you from performing everyday activities as it causes pain and discomfort in the knee. It makes squatting, bending, kneeling, climbing stairs, and walking painful. There are over-the-counter medications to help relieve the pain, some patients have benefited from an exercise program, and weight loss is another consideration to ease the pressure from your knees. If these non-surgical treatments do not work, you may be ready to consider a knee transplant.
- Changes in Lifestyle
When a knee starts giving you pain, it might help to lose weight and exercise. Your doctor can recommend exercises that will help to reduce pain. Sometimes walking more helps to decrease the amount of pain one feels if the osteoarthritis is mild to moderate.
- Physical Therapy
A physical therapist can teach you new ways to improve your posture and perform functions such as how to get up and down safely from a sitting position. They can also show you how to use assistive tools such as a walker or cane. Walking can be done to strengthen your muscles.
Your doctor can recommend some over-the-counter medicines that will help to reduce pain and inflammation. Ibuprofen, steroid medications, and corticosteroid injections are all possible alternatives as they are non-steroidal anti-inflammatory drugs. Your physician should monitor these drugs if you decide to use them.
When the non-surgical alternatives no longer work or do not reduce your pain levels, you will need to talk to your doctor about a knee replacement. Replacing a knee has become a popular alternative for people suffering from limited use of their knees, or who suffer constant pain in their knees. Having a knee replacement is sometimes not a choice for patients as there are no alternatives to remove their pain; some choose to have one to give themselves a more active life. Sadly, though, some knee replacements have caused more pain and suffering than what a patient started out suffering.
There has been a recall on several types of knee replacement devices. Some patients have had knee replacement surgery, and are now suffering more from side effects than their original problem gave them and are facing revision surgeries. Side effects from knee replacement surgery include:
- Severe damage to the muscle, bone, and nerves near the implant
- Severe and persistent pain
The FDA issued a Class I recall of Stryker’s ShapeMatch Cutting Guide in April of 2013. Surgeons used these guides to position components by marking the bone. Stryker has already stated in 2012 that they were aware of the defects and state they had advised surgeons to stop using the guide.
The software in the guide was causing surgeons to make a wider cutting range than was necessary. This cutting range meant the patients suffered more injuries, and their joints became unstable. It also resulted in limited movement and chronic pain for those with replacements done by this guide.
Other recalls on Stryker knee devices include:
- Scorpio PS and CR components
- Duracon Total Knee
- Unicompartmental Knee System
Lawsuits Involving the Stryker Knee Replacement
The ShapeMatch Cutting Guide put out by Stryker Corporation was recalled due to inaccurate bone cuts it was showing. Patients who had their surgery done under this guide’s information may have received a poorly fitting Triathlon Knee Replacement. This poor-fitting device can cause looseness in the joint, pain, disability, joint instability, and may require revision surgery.
Both the FDA and Stryker have recalled this guide after more than 40 incidents were reported to the FDA regarding the dangers involved with this software. Lawsuits were filed for injuries which included malfunctions of the knee replacement and other temporary issues including:
- Nerve damage
- Misaligned knee implant
- Knee discoloration
- Loose and unstable knee
- Permanent disability or unstable knee
- Chronic pain
- Fracture of bone or implant
- A decrease in the ability to walk
Mass Torts against Stryker Devices
An MDL is a grouping of multiple civil cases together that share a common complaint and put them before a single district court rather than having all individuals cases heard before numerous judges in several court districts. The reasoning behind this form of a court proceeding is to streamline court dockets and promote a consistent ruling for all the different lawsuits that relate to similar legal issues. The mass tort works well for large, complex cases that involve dangerous devices such as those put on the market by Stryker Corporation or drugs, and product liability.
Many of the cases originally filed as individual cases against the Stryker Corporation have now gone into MDLs. These are now consolidated lawsuits filed on behalf of a large group of people. Though state and federal Stryker cases follow separate court procedures, case schedules, and rules, any settlements or rewards reached in one court system will impact the outcome of the cases in other systems.
Find a Mass Tort Near Me Regarding Stryker Hip, Shoulder, and Knees
Needing an implant surgery is stressful and painful; you shouldn’t have to suffer from defective devices, making your life more miserable or permanently damaged. Contact Consumer Alert Now at 800-511-0747 if you have received a defective hip, shoulder, or knee implant device from the Stryker Corporation. We are ready to discuss your options and determine if you are entitled to compensation for the pain and suffering you are experiencing.