In our representation we find that our clients are hungry for information regarding the Stryker hip implant recall and the health effects associated with the recalled device. Unfortunately, we are finding that many clients are unhappy and often unable to get answers to questions they have from their surgeon and other trusted sources in order to evaluate their need for monitoring and/or revision surgery. To that end, we have devised the Top 10 Things All Stryker Hip Implant Patients Need To Know to further address many of the common questions we are asked. We sincerely hope this information will help better inform those affected by the Stryker Rejuvenate and ABG II Modular-Neck Stem hip implant recall and make everyone aware of both their medical and legal options.
1. Why were the Stryker Rejuvenate and ABG II Modular-Neck Stem Hip Implants Recalled?
On July 6, 2012 – Stryker announced it had voluntarily recalled its Rejuvenate and ABG II modular-neck stems. The issue stems from mechanically assisted corrosion and release of metal ions of Cobalt and Chromium that affect surrounding tissue and bone over time. The company was non-specific in its press release as to the exact reason or failure rate.
“While modular-neck stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, given the potential risks associated with fretting and corrosion at the modular neck junction, Stryker Orthopaedics decided to take this voluntary action,” said Stuart Simpson, Vice President and General Manager, Hip Reconstruction.
Stryker’s Rejuvenate Modular system was approved by the Food and Drug Administration (FDA) in June 2008. The ABG II system received FDA approval in November 2009. The earliest implanted devices that we have seen were in late 2010 because of the timing to distribute and market the new product to physicians.
2. What signs or symptoms do I look for if my hip implant is failing?
You may be having pain around your hip, difficulty walking, inflammation or other symptoms. Your physician has the ability to evaluate you to determine if you are at a greater risk of injury or complication. The inflammatory response from the metal sometimes occurs with little or no symptoms until there is harm to the surrounding tissue and loss of bone. An early X-ray is good to look at bone and device placemen, but without an MRI or blood work to measure the metal ion levels, a patient may not recognize the harms that may be occurring until they develop symptoms. Your orthopedic surgeon can help you with these matters. Call their office to discuss your plan of care and treatment.
3. Why in particular is the level of Cobalt important and what is the FDA saying about monitoring?
Cobalt is one of the many metals that is found naturally in the body, but as is common with most all metals, levels in excess can become toxic and lead to many harmful and potentially harmful side effects. Cobalt poisoning has caused cardiomyopathy, hypothyroidism, and neurological damage as well as impairing the sense of sight and hearing. As far as the device goes, excess amounts of cobalt in the bloodstream lead to inflammation which can seriously damage surrounding tissue and bone.
If the Doctor does not independently research studies regarding toxic values of Cobalt, patients will likely not be informed if the level of cobalt present in their blood is actually elevated, or even toxic, thereby subjecting them to prolonged issues and injuries.
Here are the overall guidelines issued January 17th on the FDA website that I believe will now become standard of care.
Information about Imaging and Metal Ion Testing
4. Is additional surgery necessary?
That is a question for your physician and the evaluation must be made in the cost benefit analysis of the potential harms of removing the device to that of replacing it all together. Many factors such as one’s age, health, weight and other risk factors must be carefully considered. See your orthopedic surgeon to discuss this potential problem and other avenues of medical treatment to see what is best for you and your family. You will find that surgeons that are experienced with the harms from this device may not be the same surgeon that put in the device. You may also want to get a second opinion and ask what components are going to be utilized and if the physician is limited by contract or experience to a certain manufacturer. Experience related to this modular component matters. Stryker in 2012 even has released an extraction protocol for the benefit of the surgeon. http://literature.ortho.stryker.com/files/LSP70.pdf
5. Are there any risks to having revision surgery?
There are risks to having any type of surgery but knowing more about the procedure and how to deal with it is key. This is a very painful and complicated procedure. A second hip surgery is usually longer and more intense than the first and not all patients are candidates for a revision surgery. Only a trained medical doctor can make this determination with you after conducting the requisite blood tests, x-rays, MRIs and other medical examinations.
6. Who is Broadspire and what is their role in the recall?
Broadspire was announced to have been hired by Stryker on or about January 3, 2013 According to reports, Broadspire is a division of Crawford and Company that is touted as the world’s largest insurance and claims adjuster. Broadspire is funded by Stryker to gain access to the medical records of patients affected by Stryker’s recent hip implant recall through medical authorizations. There can be a benefit to the uninsured patient seeking reimbursement for medical expenses or gaining approval to have expensive procedures paid for by the company, but keep in mind that making a claim for out of pocket expenses or medical bills not paid for by insurance is all that Broadspire is really doing based on our findings. If your claim is not filed in a civil action before the expiration of the statute of limitations, you will not be able to pursue a claim for the harms that you have experienced, or may experience, in the future including but not limited to pain and suffering from the recalled Stryker hip implant.
7. What responsibility does my Physician have ?
One common question many patients have is what responsibility, if any, do the doctors and/or orthopedic surgeons that implanted these have in this nationwide Stryker hip implant recall. Our firm’s research and findings are clear: NONE in the cases we have seen and reviewed to date. Stryker has failed to convey their findings on the increasing failure rates of Stryker Rejuvenate and ABG II Modular-Neck Stem devices to surgeons and made the product that was defective.
8. Should I hire an attorney?
Along with the medical costs from eventual hip replacement revision, a failed hip replacement can cause a lot of other hardships, including effects on the patient’s lifestyle. Too many patients with defective hip replacements struggled through extensive rehabilitation therapy to pursue a more active life after the hip replacement only to have their activities slowly restricted again when the Stryker systems began to manifest problems. The representation of our clients is on an individual one-on-one basis. We are not representing folks in a class action basis, nor do we believe it would be in your best interest to be in a class action. Our firm is committed to zealous and effective representation of clients who are affected by this defective device for all harms associated with this recalled device. Stryker claims it will cover reasonable and customary costs of monitoring and treatment but, in reality, Stryker’s intentions may not be so transparent. Stryker has requested that patients submit all of their bills to private health insurance (including Medicare and employer sponsored – ERISA – health insurance plans), offering only to pay the patient’s out-of-pocket co-pays and deductibles. This is an excellent deal for Stryker, but not justice for the patient or your health insurance carriers who are in essence paying for Stryker’s mistakes.
9. What are examples of harms that are evaluated in a civil suit against Stryker and related entities?
A jury can consider the following list concerning non-economic factors for the Stryker Rejuvenate and ABG II Modular-Neck Stem hip replacement recall lawsuit:
1) Any lost wages or loss of earning capacity;
2) The effect the Stryker hip injury had on the individual’s overall mental and physical well-being;
3) The duration and extent of the injury the individual suffered;
4) The mental anguish and pain suffered by the individual;
5) The amount of past or future medical expenses was caused by the defective Stryker Rejuvenate and ABG II Modular-Neck Stem hip replacement implants;
6) The extent of any disfigurement or any scarring that was caused by the defective Stryker Rejuvenate and ABG II Modular-Neck Stem hip replacement implants.
10. Should I surrender my defective hip implant to the company?
You should ask an attorney about this question. Our position is that you should retain the hip implant hardware with an approved medical device retrieval company per an agreed protocol. We have retained a company that works directly with the hospital and surgeon in having the device preserved for any subsequent testing and/ or failure analysis. This is a very important decision because the removed hardware will become critical evidence in your claim against Stryker in the days ahead. It is your hardware because you paid for it so do not let anyone tell you anything to the contrary. If you have questions about the retention of your implanted hardware give us a call as we are happy to help.