Stryker Reiterates Rejuvenate And ABG II Recall Information

Manufacturer Reminds And Patients And Professionals Of Issue

14.11.2014

Medical device manufacturer Stryker has issued a product recall update to reiterate the key information regarding its long-running voluntary recall of both its Rejuvenate and ABG II modular-neck stem devices for hip replacement, with cases related to the equipment also settling in the US.

The company has issued another letter on the matter to follow up from its previous communications related to the products, which were first the subject of a recall in June 2012 when post-market surveillance data identified potential risks of fretting and corrosion at the modular neck junction.

Following that, another communication in January 2013 offered key recommendations for medical professionals, including that surgeons should perform clinical examinations regardless of whether a patient is experiencing pain or swelling.

It added that a routine follow-up examination should also be offered even in the presence of normal initial findings and surgeons should evaluate patients for aseptic loosening and periprosthetic sepsis.

Stryker also reiterated in the document that it was committed to reimbursing patients who have incurred expenses due to testing, treatment or any necessary revision surgery. Full details of the affected components have been placed on the Stryker website.

News of the recall came just before it was confirmed that Stryker intends to settle thousands of cases in which people suffered complications after being fitted with either its Rejuvenate and ABG II modular-neck stem devices.

Expert Opinion
The voluntary recall on these products has been in place now for around two years, yet the manufacturer clearly feels there is a need to reiterate the key points regarding the issue and how medical professionals should approach relevant cases. This raises concerns as to whether the full regulatory powers available to the MHRA are being utilised effectively.

"It is imperative that surgeons and medical staff pay close attention to this notice and ensure that they comply with the recommendations, with the ultimate aim of preventing further patients from suffering complications with these devices. It is equally important that the MHRA takes a more proactive approach in the enforcement if the regulatory regime placing a stronger focus on patients who are at risk of harm from medical devices.

"In tandem with this, it is vital Stryker continues to work to determine what can be done to prevent such problems emerging on other devices in the future. A patient focused approach should always take priority over the speed at which a product gets to market. Having seen the impact that device failings can have on so many people, it is vital that lessons are learned to protect people going forward."
Kevin Timms, Solicitor