Rejuvenate Modular / ABG II Modular-Neck Stem Voluntary Recall
Information about the Voluntary Recall:
In June 2012, Stryker initiated a voluntary recall of its Rejuvenate and ABG II modular-neck hip stems. While modular-neck hip stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, we decided to voluntarily recall these modular-neck hip systems due to the potential for fretting and corrosion at the modular-neck junction which may result in ALTR (adverse local tissue reactions), as well as possible pain and/or swelling at or around the hip.
Surgeons should consider performing a clinical examination, such as blood work and cross section imaging on all patients who received a Rejuvenate or ABG II modular-neck hip stem regardless of whether a patient is experiencing pain and/or swelling. Repeat follow-up examination, such as blood work and cross section imaging, should be considered even in the presence of normal initial findings. For further information regarding patient follow-up please refer to the Product Recall Update.
Information about Reimbursement:
As part of our commitment to support patients and surgeons affected by this matter, Stryker will be reimbursing patients for testing, treatment, revision surgery, if necessary, and other costs relating to this voluntary recall. Beginning immediately, Stryker is partnering with Broadspire Services, Inc., a leading third-party claims administrator, to manage requests for reimbursement of costs relating to the voluntary recall of the Rejuvenate and ABG II modular-neck hip stems.
Information for Patients:
Stryker suggests that patients who have received a Rejuvenate or ABG II modular-neck hip stem contact their surgeon to schedule a follow-up appointment even if they are not experiencing symptoms such as pain and/or swelling at or around their hip.
In an effort to provide you and your office staff with support, we have established a Stryker Patient Care Line which can be reached at 1-888-317-0200, 8am – 9pm EST, Monday through Saturday. Please advise your office staff to refer patients with questions regarding the voluntary recall and claims to the Stryker Patient Care Line.
The patient website has been updated to reflect this information.
Additionally the following resources have been developed to assist you and your office staff in communications with patients:
Click here to view the following:
- Evaluation of Painful Total Hip Replacements Modular Metal Taper Junctions,R. Michael Meneghini, MD - PDF
- Rejuvenate Modular Extraction Protocol - PDF
- ABG II Modular Extraction Protocol - PDF
- Medical Authorization Form - PDF
Please feel free to contact us with other questions related to these matters:
Clinical matters Contact:
Dr. Jon Hopper, Stryker’s Vice President, Global Medical Director,
Regulatory matters Contact:
Colleen O’Meara, Manager, Divisional Regulatory Compliance,
at 201-972-2100 or firstname.lastname@example.org
Product matters Contact:
Jonathan Sacks, Sr. Director, Global Femoral Brand Marketing, Global Hip Reconstruction Business Unit
at 201-831-6398 or email@example.com