Stryker Recall of Rejuvenate and ABG II Metal-on-Metal Hip Systems

Stryker Recall of Rejuvenate and ABG II Metal-on-Metal Hip Systems. Following concerns over the potential for fretting and corrosion, Stryker have voluntarily recalled the Rejuvenate Modular and ABG II modular-neck hip stems used in metal-on-metal hip implants.

Their decision was based on fears that the components contributed to corrosion and subsequent adverse local tissue reaction. Stryker also recalled the MITCH THR System with uncemented Accolade stem in April.

Stryker will be working with the medical community to better understand and address the issue. Stryker funded researchers say that modular neck stems were thought to offer better precision, and “provide the surgeon the unique advantage to more exactly reproduce or correct the patient’s anatomy and hip biomechanics.”

Healthcare professionals and regulatory bodies have been advised of this voluntary recall. Patients who received a Rejuvenate Modular or ABG II modular-neck stem and who are experiencing pain and/or swelling should contact their surgeon. If you are uncertain about which medical device implant you have, you should contact your doctor, surgeon or the hospital where you had your surgery and request your medical records.

If you are a public patient, you are entitled to copies of your medical records under the Freedom of Information Act, however there are search and retrieval fees. The Data Protection Act applies to those considered to be ‘Data Controllers’ such as doctors, private hospitals and medical centres. A Freedom of Information or Data Protection request should always cite the legislation under which the request is being made. You can also sign an authority for your solicitor to write to the appropriate person or entity seeking copies.

If you have any queries in relation to issues raised in this article please email us at hips@mlaw.ie or phone 01 8744 422.