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 stem 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 sectional 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 (a Crawford Company), 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.
Please advise your office staff to refer patients with questions regarding the voluntary recall and claims to Broadspire at toll-free number 0808 2381788 or +44(0)1908 302344.
Additionally, the following resources have been developed to assist surgeons with communications to patients:
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 at +1-201-972-9140 or firstname.lastname@example.org
Product matters Contact:
Tom Baker, Hip Product Manager at (+44)7770 684531 or email@example.com
Regulatory matters Contact:
Daniel Rana, RA/QA Manager at +44 1635 262402 or firstname.lastname@example.org