Stryker Modular-Neck Stem Hip Implant Component Recall
In July 2012, Stryker Orthopaedics issued a voluntary recall of their Rejuvenate and ABG II modular-neck stems. These components are used with many of their hip implant systems in order to create a better fit between the hip implant and the patient’s anatomy.
The recall was prompted by numerous reports of safety issues associated with these modular-neck stems. Since January 2012, the FDA has received at least 45 reports of adverse events associated with the Rejuvenate and ABG II modular-neck stems. A spokesperson from Stryker announced that the potential risks associated with these defective medical devices outweigh their benefits, making this recall the best course of action.
Problems Associated with Stryker Modular-Neck Stem Devices
While the Stryker Rejuvenate and ABG II modular-neck stems can be used with either metal or ceramic hip implants, the neck stem components utilize a metal-on-metal design. These components have experienced similar issues that have recently been associated with other metal-on-metal hip implant devices. The friction created when these modular-neck stems move leads to fretting or corrosion, which can release toxic metal debris into the bloodstream.
Complications associated with this influx of metal particles in the bloodstream include:
· Tissue damage
· Metallosis (metal poisoning)
· Bone loss
· High implant failure rates
Many patients require revision surgery to correct these issues, and revision surgery carries additional risks to the patient. Stryker has informed healthcare professionals and regulatory agencies of the recall. If you have received one of these modular-neck stems as part of a hip implant procedure, you should contact your surgeon for additional information.
This is not the first time Stryker has experienced problems with defective hip implant device components. In April 2012, Stryker recalled the Accolade femoral stem which is commonly used with their MITCH TRH modular head/acetabular cup hip implant due to multiple reports of high revision rates associated with the component.
Fighting for You
If you have experienced complications or adverse reactions after receiving a hip implant using the Stryker Rejuvenate or ABG II modular-neck stems, you may be entitled to receive compensation for damages such as:
· Medical expenses
· Lost income
· Pain and suffering
The product liability attorneys at Wapner Newman have been fighting for the rights of injury victims for more than 40 years. We have extensive experience handling cases involving a variety of defective medical devices, and we understand the complex medical principles involved in these cases. Our attorneys are committed to devoting the time and resources necessary to helping you receive the compensation you deserve.
Please contact Wapner Newman today to schedule your free initial consultation. We serve clients throughout Pennsylvania and New Jersey with offices in Philadelphia, West Conshohocken, Allentown, and Marlton.