July 6, 2012: Stryker Orthopaedics, a publicly traded company and a prominent designer and manufacturer of prostheses and medical devices, recalled two of its hip implant models. This recall was premised on the fact that the hip prostheses in question are prone to “fretting and corrosion” that could trigger pain, swelling, and other complications in patients.
Similar to hip failures by manufacturers such as DePuy, Wright Medical, and Zimmer, countries that register medical devices have been the first to warn of failures. In the case of the Stryker Rejuvenate, the Canadian regulatory body, Health Canada, recalled the Stryker Rejuvenate back in April of 2012. This was not the only problem that Stryker has had with its devices either. Also in April, the Australian and New Zealand Departments of health recalled the Stryker MITCH TRH Modular Head due to premature failure.
Stryker’s Rejuvenate Modular and ABG II modular-neck stem devices are both what is known as metal-on-metal devices. This entire group of prostheses, from a variety of different manufacturers, has been called into question recently by the legal and medical community. In fact, the FDA has formed a special panel to address the problems.
In regard to the Rejuvenate Modular and ABG II modular-neck stem devices, Stryker is informing patients who have been implanted with one of the recalled devices to contact their physician immediately. Meanwhile, the company has stopped global production of the devices.
Act Fast to Preserve Your Right to Compensation
Both Stryker hip replacement models were approved through the 510(k) process, meaning neither model was subjected to testing or clinical studies before being used in actual patients.
Stryker conducted post-market surveillance, but the implants had already been installed in a large number of patients. Upon surveillance, it was discovered that the modular-neck stem was susceptible to corrosion and fretting.
Known complications arising from these models include:
- Blood toxicity from metal debris, potentially resulting in chronic pain, inflammation, loss of vision or hearing, gastrointestinal disorders, cardiovascular issues, and more
- Death of surrounding tissue (necrosis)
- Hip dislocation
- Broken bones around the site of the implant
If you received a Rejuvenate or ABG II hip implant, it is recommended that you contact your surgeon. If you are uncertain if you have one of these models, consult your surgeon or your medical records.
Even if you have already attempted to take legal action for problems with a Stryker Rejuvenate or ABG II hip implant and been turned away, you may still have a case. The primary hip joint in both of these models does not create metallic corrosion and fretting, since it is made of ceramic. Because of this, many patients seeking legal counsel for issues with this device were initially turned away. Since that time it has come to light that the femoral neck and the hip stem are the components that fret and corrode, causing metal fragments to come lose. This inherent flaw in these two implant models is irrefutable, giving you a second chance at the compensation you deserve.
If you have received a Stryker hip implant and have experienced any adverse effects, you may have a case. Please contact our office to speak with one of our Stryker Hip Implant Attorneys. It will cost you nothing to find out what might be done in your situation and we collect no fees until we win your case.