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Thursday, November 8, 2012

Why Patients Aren’t Getting the Message Regarding the Stryker Rejuvenate and ABGII Recall

Despite a Stryker Orthopedics recall in July of 2012 for the company’s Rejuvenate and ABGII hip implant devices, recipients of the devices are simply not getting the information they need about potential implant hazards. Canada, who appears to be a bit ahead of the curve when removing potentially dangerous medical devices and drugs from the market, experienced a recall of the implants almost two months earlier. An Urgent Safety alert was sent out by Stryker to physicians and hospitals in April of 2012, advising that there could be potential problems with the hip implants.

This Safety Alert stated that the potential hazards of the Rejuvenate and ABGII include: “Excessive metal debris and/or ion generation. Fretting and/or corrosion at or about the modular neck junction may lead to increased metal ion generation in the surrounding joint space.” Even though Stryker is aware of the potential safety risks of these two hip implants and issued a voluntary recall, they have yet to create a specific program which will both identify those with a Rejuvenate and ABGII as well as aid hip implant recipients in getting the help they need.

Should Stryker Follow DePuy’s Lead for Their Recalled Hip Implants? 

Although Johnson & Johnson announced a method which would allow DePuy ASR victims to get assistance shortly after the recall was issued, Stryker has yet to follow up with similar help for their implant recipients. Johnson & Johnson and its subsidiary, DePuy, hired a third party – Broadspire Services, Inc. - to administer patient claims associated with the ASR recall. Broadspire generally manages workers compensation and other medical claims on behalf of insurance companies and employers, so many were surprised that DePuy and Johnson & Johnson had chosen this route.

Nonetheless, recipients of the ASR felt like DePuy was at least doing something to help them get the treatment they needed while recipients of the Rejuvenate and ABGII have received nothing at this point. The process of physician notification can be laborious and slow which means that a fair number of the estimated 30,000 – 50,000 recipients of the Rejuvenate and ABGII have yet to receive notification of the potential risks of their hip implant.

Stryker’s Response to Implant Recipients

Many believe Stryker should be much more aggressive in implementing a program to help those affected by the recall. Even in the official statements on their website, Stryker’s response was somewhat lackluster as they advised those who had received either a Rejuvenate or ABGII to contact their surgeon if they noticed any undue pain or swelling around the hip joint while further stating that “If you have no symptoms, you should continue to follow the post-operative plan that your surgeon has outlined for you.” Should you believe your recalled Rejuvenate or ABGII hip implant is a risk to your health, it could be beneficial for you to seek legal advice. 

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