Stryker has voluntarily recalled its Rejuvenate and ABG II modular-neck stems because of post-marketing surveillance data which suggests a potential risk of what is termed “fretting” and corrosion.
When it comes to implants, especially hip implants, the medical device industry gets extremely jumpy if there is the slightest hint of a problem, let alone one that hints at metal particles. And for good reason, given the all-metal hip disaster of recent times. What all sensible folk are advocating in order to head off at the pass future implant problems is a heightened focus on post-marketing surveillance data, which it seems has provoked Stryker’s action. Continued post-market surveillance has uncovered a risk of fretting and corrosion at the modular neck junction, to the extent that the company has decided to voluntarily remove Rejuvenate and ABG II modular-neck stems and terminate global distribution of these products.
In a press release, issued via PR Newswire the company expresses the view that this post-market surveillance data may be predictive of a trend.
Stryker tells us it has notified healthcare professionals and regulatory bodies of this voluntary recall, presumably on a global basis.
Advice for patients is that those 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.
“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.
“Following this action, we will work with the medical community to better understand this matter as we continue to evaluate the data,” said Simpson.
Source: Stryker inc., PR Newswire