Australian Officials Recommend More Clinical Testing, Imaging for Patients Affected by Stryker Hip Recall
Stryker officials in Australia are now recommending that all patients implanted with devices affected by last summer’s Stryker hip recall undergo routine blood testing and soft tissue imaging, even if they are not experiencing any pain or swelling, MassDevice.com reports.
According to the article published Feb. 20, the new guidelines for following up with patients who received the Rejuvenate and/or ABG II modular-neck hip stems were upgraded from July 2012, when Australia’s Therapeutic Goods Administration said to do so only they are suffering pain and swelling that may be caused by wear and tear of the implant.
New Patient Follow-Up Regulations Issued After Stryker Rejuvenate Recall
Now, revised regulations now tell doctors to repeat follow-up, evaluation and potential revision surgery for patients whose clinical test results indicate evidence of metallic debris in the blood stream. Patients not exhibiting symptoms should still be monitored, however.
Australian regulators say this is because multiple asymptomatic patients have reportedly developed soft tissue injury soon after their initial evaluation. At least one patient’s test results later showed heightened metal levels in the blood stream and soft tissue damage, Mass Device reported.
Could these new guidelines be partially owed to the mounting number of Stryker hip recall lawsuits filed on behalf of patients who allegedly suffered side effects stemming from the Stryker hip recall, not to mention the fact that 10,000 Rejuvenate hips were sold throughout the U.S. prior to July 2012?
On the day of the Stryker hip recall, which was announced by Stryker Orthopaedics after post-surveillance data indicated there to be a potential for the implant to fret and corrode at the modular-neck junction, the manufacturer released the following statement:
“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,” according to a press release issued alongside the July 2012 recall. “The post-market surveillance data may be predictive of a trend.”
The following side effects have been reported by patients affected by the Stryker hip recall:
- pain and/or swelling at the local joint site;
- inflammation of the surrounding tissue; and
Considering a Stryker Hip Recall Lawsuit? Contact Us Today.
If you suffered the above complications associated with the Stryker hip recall, you may be eligible to receive compensation for your injuries by filing a Stryker hip lawsuit. Call a lawyer at Bernstein Liebhard LLP at (877) 779-1414.