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6
July
2012
Stryker Initiates Voluntary Product Recall of Modular-Neck Stems - Action Specific to Rejuvenate and ABG II Modular-Neck Stems
July 6, 2012 - Stryker has voluntarily recalled its Rejuvenate and ABG II modular-neck stems.
"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 Orthopaedics’ decision to voluntarily remove Rejuvenate and ABG II modular-neck stems and terminate global distribution of these products comes after continued post-market surveillance. The post-market surveillance data may be predictive of a trend. "Following this action, we will work with the medical community to better understand this matter as we continue to evaluate the data," said Simpson.
Stryker has notified healthcare professionals and regulatory bodies of this voluntary recall. Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to contact their surgeon. Patients uncertain if they have one of these products implanted should contact their surgeon or consult their medical records.
A dedicated patient call center can be reached at 1-888-317-0200 and additional information can be found at www.AboutStryker.com/ModularNeckStems
Safety Announcement
Stryker recalled its Rejuvenate and ABG II hip stems in July 2012, after data indicated the metal hip components were vulnerable to fretting and corrosion at the modular neck junction. When this occurs, Stryker hip replacement recipients may experience pain, swelling and adverse local tissue reactions. Since the recall, all Rejuvenate and ABG II hip stem recipients have been advised to undergo metal ion testing and cross sectional imaging, even if they are not experiencing symptoms of a failing hip implant. Stryker issued this advice after the company received reports that some patients had experienced high levels of metal ions in their blood and/or adverse local tissue reactions, even in the absence of symptoms
People whom have been injured by the Stryker hip do have legal options
How Soon Should You Seek Legal Advice? You may wonder whether your situation is bad enough to warrant legal action.
So don’t hesitate to find out what your rights are as soon as possible. There’s a good reason for that: The Statute of Limitations.
The Statute of Limitations means that your rights for compensation expire after a certain time, and you definitely don’t want that to happen to you.
You may not be able to continue working or taking care of your family, and may need to hire somebody to assist you. When a drug manufacturer or medical device manufacturer, puts patients’ and well-being at risk, the American legal system has remedies available. These include:
- Mass Torts and Multi District Litigation: A mass tort is when a group of plaintiffs file their legal proceedings in a state court, while a multi district litigation (MDL) is held in a federal court.
- Class Action Lawsuit: In a class-action lawsuit, plaintiffs with similar injuries all combine into one single lawsuit.
- Individual lawsuits: In an individual lawsuit, the injured party sues the drug manufacturer directly both for the expenses that they have incurred as a result of their actions and for punitive damages.
- Get your free case evaluation now!
Our firm works on a contingency basis which means you will not be asked to pay any money out of pocket.
This process will be very easy. Please feel free to answer all questions honestly as your information is confidential.
Common Stryker Hip Replacement Side Effects
The U.S. Food and Drug Administration (“FDA”) has received over 60 reports of Stryker hip injuries from patients who suffered from Stryker hip side effects. If you have received a Stryker Rejuvenate or ABG hip implant, you are rightly concerned about Stryker hip side effects. Symptoms of Stryker hip injury may include inflammation, painful walking, moving of the legs or standing. Signs of Stryker hip injuries include:
- Loosening of the metal implant, separating from the bone
- Muscle injury
- Pseudotumors
- islocation of the implant, when the metal component detaches from the hip
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