The Stryker Orthopedics Rejuvenate and ABG II modular-neck hip stems have been voluntarily recalled. It was on July 6, 2012 that the company recalled the product due to corrosion and fretting risks at the modular neck junction, resulting in adverse reactions by local tissue. The recall forced the company to stop production of these products.
This cessation of production comes after a post-market surveillance of data that has identified a trend in the failure of these products. Stryker states that they will be working with the medical community in order to better understand what is occurring with the devices to prevent the issue in the future.
As for how they have failed, the modular design of the Stryker products consists of a stem and a neck. The recall came after a Journal of the American Academy of Orthopaedic Surgeons article stated that all modular-neck hip stems posed potential risks. While the product poses a great number of benefits, it was found that the disadvantages possibly outweighed the advantages. The primary disadvantage was the fact that corrosion could result in debris and metal ions being released within a person’s body.
It was around the time of the article that Stryker sent distributors an Urgent Field Safety Notice regarding the Rejuvenate and ABG II. The notice stated that it was possible that metal debris, as well as ion generation could result, and so can fretting and/or corrosion in the area of the modular neck junction.
Consequences Of Metal Ions
If metal ions are released into the body, the consequences include:
- Revision surgery
- Adverse local tissue reaction
- Allergic reaction to the ions, resulting in revision surgery
Currently, the statistics state that the adverse local tissue reaction rate is less than 0.5% of the patients who had received the devices. The incidence of complications are deemed low at this time, but the need for individuals to consult with a Minnesota personal injury lawyer could increase as more of these devices possibly fail in the patients who received them prior to the recall.
To know whether or not you received the Rejuvenate or the ABG II, you can speak to your surgeon and they will tell you. You also have the right to review your medical records for the identification of the specific implant that you received. If you are feeling pain or experiencing swelling around the implant, you should contact your surgeon as soon as possible. If you have no pain, you should arrange for a follow-up with your surgeon to check the implant.
Contact A Minnesota Personal Injury Lawyer
If you have experienced complications related to the Stryker Rejuvenate or ABG II, see your surgeon immediately. Revision surgery may be required to keep the device from making you ill. Once it is determined that there is a problem with your implant, you can call TSR Injury Law at 612-TSR-TIME to set up your free consultation. We will evaluate your medical records and advise you of what the process entails when filing a claim against the manufacturer to pay for any past or future revision surgeries, medical bills related to device complications, and any other damages you may be entitled to.