The FDA today confirmed a Class I recall for the Zimmer Biomet (NYSE:ZBH) Rosa One 3.1 Brain Application platform for robot-assisted neurosurgery procedures.
Zimmer Biomet sent an urgent medical device correction on Sept. 22 for the platform as a result of a software error. Affected devices — of which there were 119 total in the U.S. — were distributed between Dec. 1, 2019, and Aug. 31, 2021, according to an FDA notice.
The company recalled the product due to a software error that could lead to the incorrect placement of instruments during stereotactic neurosurgical procedures, which could result in adverse events including stroke, serious injury, severe disability and death.
In total, there have been three complaints about the device issue with zero deaths or injuries reported.
Warsaw, Indiana-based Zimmer Biomet designed the Rosa One 3.1 Brain Application to help neurosurgeons with positioning medical instruments or implants during surgery. The device includes a robotic arm and a touch screen mounted on a stand, while a variety of medical instruments or tools (such as biopsy needles, stimulation or recording electrodes, endoscopes) may be attached to the end of the robotic arm, depending on the type of procedure.
A previous version of the robotic platform experienced similar issues when, in September 2019, a software glitch with the Rosa Brain 3.0 devices resulted in a device warning. No long-term adverse events were reported from the problem, in which a sequence workflow can trigger “a discrepancy between initial skin marking on the skull and instrument trajectory.”
According to a Zimmer Biomet spokesperson, the Rosa Spine, Rosa Total Knee, Rosa Partial Knee and Rosa Hip application systems are not affected by the software anomaly as the issue is specific to the Rosa One 3.1 Brain Application system.
The spokesperson noted that the company notified users of a software upgrade to address the anomaly and, until that upgrade is completed, users were provided instructions to follow in order to address the anomaly. While the upgrade is being implemented, Zimmer Biomet will work with surgeon users to ensure there is no disruption to their ability to safely perform procedures. The company also self-reported the need for the software upgrade to the FDA.
“Zimmer Biomet has recently identified a rare anomaly that can occur in the brain software application deployed on Rosa One 3.1 robots. Specifically, when a particular sequence workflow in the brain software application is utilized, an unplanned calibration of the mounted tool occurs that can result in inaccuracy of the tool trajectory,” the spokesperson said via email. “Since the installation of the impacted software beginning in December 2019, there have been three global complaints related to the software anomaly out of approximately 3,600 surgeries performed. No patient injuries were reported.
“Zimmer Biomet is dedicated to patient safety, and quality excellence is an integral aspect of our commitment to the patients and surgeons who rely on our products every day. We stand behind our products and will deploy upgraded brain software for Rosa One 3.1 units that are on the market today in a comprehensive and timely manner to ensure quality, safety and efficacy.”
This story was updated with a comment from Zimmer Biomet.
