Stryker Hip Recall: Rejuvenate & ABG II Implant Devices
Stryker Orthopaedics, which is a well-established medical technology company dealing in the manufacture of materials used in surgery and other medical treatments, encountered legal and medical problems arising from the recall of its Rejuvenate and ABG II modular-neck hip implant devices. They were promoted as adequate replacements for patients who needed total hip replacement; their designs, however, were discovered to have fatal defects that caused significant harm to the patients. This situation was not only disastrous in as much as it touched on the lives of thousands of patients but also regarding litigation against the company.
Below, we will describe the details of the Stryker hip recall, the problems linked with Rejuvenate and ABG II implants, and the subsequent legal activities of the patients these products impacted.
Stryker Hip Recall: Rejuvenate and ABG II Implant Devices
Stryker Rejuvenate and ABG II hip implant systems were developed as newer, more flexible, and more adaptable than the general hip implant. The integrated modular neck systems were designed to match a patient’s anatomy better to increase movement and decrease the likelihood of dislocation. Yet after these devices were inserted into patients, adverse effects were documented. The main problem was the wear of the metal ions in the body because fretting and corrosion occurred at the modular neck junction of the titanium and cobalcobalt-chromium alloy. This resulted in metal ion release, leading to metallosis and inflammation, discomfort, and tissue loss around the implant area.
However, with increased reports of such complications, Stryker offered a voluntary recall of Rejuvenate and ABG II devices in July 2012. The recall was to prevent additional patients’ injuries since numerous patients had undergone adverse consequences necessitating revision surgery-another more complicated surgery to replace the implants.
The recall pointed those dangers to metal-on-metal hip implants, which had been a concern in the medical world because of problems with other manufacturers’ devices.
Stryker Hip Lawsuits
After the recall, many thousand patients implanted with the Rejuvenate and ABG II devices sued Stryker. Stryker hip lawsuits were primarily rooted in allegations that the company did not conduct sufficient tests on the devices, did not sufficiently warn people of the possible dangers of using the implants, and wronged those who regarded them as safe when, in reality, the reverse was the truth. The plaintiffs in these cases wanted damages for medical bills, suffering, and other losses occasioned by the difficulties arising from the faulty implants.
Stryker finally settled the case in 2014, with over $1 billion being set aside for payment of thousands of complaints. This settlement was one of the biggest that applied in the history of defective medical devices and showed the extent of problems linked with Rejuvenate and ABG II systems. The legal exposures of Stryker continued beyond this settlement level since further patient lawsuits continued being filed after the offer of exclusionary dates for complaints.
Final Thoughts
The Stryker hip recall involving the Rejuvenate and ABG II implant devices vividly illustrates the dangers of medical implants and the possible outcomes of the deficiencies in the medical products’ testing and regulation. The recall and the subsequent legal actions affected the patient in many ways. In addition to the pain and suffering, many of the patients incurred substantial medical costs due to the faulty implant. Even though this case provides some justice and compensation, it is a clear example of the necessity of improving the safety of EHRUs and increasing the effectiveness of authorization and regulation in medical technologies.
