According to the U.S. Food and Drug Administration (FDA), Stryker Orthopaedics is recalling its Rejuvenate and ABG II modular-neck stems due to potential risks associated with fretting and corrosion at the modular neck junction.
Stryker Orthopaedics’ decision to remove Rejuvenate and ABG II modular-neck stems from the market and end global distribution of these products comes after continued post-market surveillance data that “may be predictive of a trend,” according to the FDA.
Hip stems are attachments to artificial hips that allow the device to fit a patient’s anatomy.
Stryker has notified healthcare professionals and regulatory bodies of this recall. Patients who are uncertain if they have one of these products implanted should consult their medical records.
Patients who received a Rejuvenate Modular or ABG II modular-neck stem are encouraged to contact their surgeon if they are experiencing complications associated with the devices – for example, pain and swelling at the local joint site.
If patients have additional questions about the recalled Rejuvenate and ABG II modular-neck stems, metal debris and/or possible physical repercussions, feel free to consult a Slack Davis Sanger medical device attorney for a complimentary case evaluation.