Why Aren’t Patients Being Notified of Stryker Rejuvenate Hip Implant Hazards?

In April of 2012, Stryker Orthopaedics issued a letter entitled “URGENT:  Field Safety Notice” which was directed to distributors, hospital risk managers, and surgeons with regard to the modular stems and necks that are utilized in the Rejuvenate Modular Hip Implant System.  This safety alert is not an official recall of the device, although a recall may certainly be in order.  This notice from Stryker indicates that it was issued to list “all known potential hazards” associated with the Rejuvenate product as well as efforts to mitigate or minimize risks to patients.  Unfortunately, many surgeons and hip implant patients with whom we have spoken are unaware of this Field Safety Notice or the recall notice that was issued in Canada on May 28, 2012.

The potential hazards outlined in the Field Safety Notice include fretting or corrosion at the modular neck junction, which can lead to excessive metal debris and/or ion generation in patients. The safety alert also indicated that patients may develop adverse local tissue reactions to the modular implant, including immunological responses, metallosis, elevated levels of cobalt in their bloodstream, pain, allergic reactions, or tissue necrosis.  It is also noted that metallic debris from the excessive fretting of the implant at the junction where the modular components meet may also lead to bone damage. Patients who develop these adverse reactions to the Rejuvenate hip implant may require additional hip implant surgeries.

Stryker’s notice indicated that it had instituted a risk mitigation policy with regard to the Rejuvenate Hip Implant System which includes updating the instructions that accompany the devices when they are delivered to surgeons in the operating room as well as ensuring that the Field Safety Notices are posted in the offices of surgeons and surgical facilities.  This strategy, however, does not appear to include the communication of this critical safety information to patients who may have been implanted with the Rejuvenate Hip System over the past few years and may be needlessly suffering due to the lack of data about fretting and corrosion of their non-MOM hip implant devices.

It is unknown at this time how many patients might be affected by this product failure.  Our law firm currently represents a number of patients from South Florida and elsewhere in the United States that were implanted over the past two years and have already experienced premature failure of the implants, elevated blood levels of cobalt, pseudotumor formation, and other adverse reactions caused by excessive metal debris generated by the yet-to-be-recalled Stryker Rejuvenate hip implant.  The FDA adverse event database and other online sources include reports from around the country involving patients who have suffered similar reactions following implantation of the Rejuvenate modular device.