In December of last year, the dental and orthopedic implant manufacturer Zimmer Biomet (ZBH) initiated an Urgent Medical Device Recall because 1 of their devices is fracturing higher than anticipated rates. This is leaving people in pain and fearful of a second surgery.
The device in question, the Comprehensive Reverse Shoulder System Humeral Tray (Model 115340), is a surgical implant which helps restore arm movement. For patients with rotator cuff tears or arthropathy, a severe type of shoulder arthritis, the Reverse Shoulder System can help them regain the life they had before the injury.
That is, if the device doesn’t fracture inside of them first. And, because of the device’s design, this nightmare scenario is happening at an alarming frequency.
This is why the Food and Drug Administration (FDA) designated the situation as a Class I recall, the most serious type of recall. According to the FDA, a Class I recall is reserved for “dangerous or defective products that predictably could cause serious health problems or death.”
Zimmer Biomet’s Comprehensive Reverse Shoulder is being recalled because these devices are fracturing at a higher rate than is stated in the labeling. If this happens, it may “may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”
The device was approved in 2008 without having been put through human clinical trials. This is because Zimmer Biomet demonstrated to the FDA that the device was “substantially equivalent” to 5 other devices which had already received the administration’s approval.
Which Devices Are Affected?
The Comprehensive Reverse Shoulder was manufactured from August of 2008 until September of 2011, and was distributed as recently as September of 2015. The device was distributed in the United States, Canada, Australia, Chile, Colombia, and the Netherlands. Over 3,600 devices have been recalled. According to Zimmer Biomet, devices manufactured after September of 2011 have design enhancements that increase the strength of the device.
Healthcare providers need to check their stock against the affected lot numbers to make sure they have notified relevant patients and so that defective devices are not used in future surgeries.
For patients who have received a total shoulder replacement with this device, they need to be given access to the real risks associated with the device inside them.
There are risks associated with any surgery, and people weigh their options based on the information they receive. If the label does accurately inform the patient of the risk, then there is a major problem.
Zimmer Biomet’s Troubles Continue in 2017
In January of 2017, the Department of Justice announced that Zimmer Biomet Holdings Inc. agreed to pay a $17.4 Million criminal penalty “in connection with a scheme to pay bribes to government officials in Mexico.” Essentially, employees and executives ignored signs of bribery, which allowed a subsidiary to import contraband dental implants.
According to Stephen Richardson, Assistant Director of the FBI’s Criminal Investigative Division, Zimmer Biomet was made aware of the misconduct and allowed it to continue:
“Zimmer Biomet failed to rectify their misconduct and get back on track in compliance with the law, and now they are facing the consequences of their corrupt actions. . . The FBI will not stand idly by when companies operate outside the law and attempt to play by different rules in the marketplace. We remain vigilant and committed to holding those accountable who disregard the rule of law in the United States.”
Hopefully, this agreement sends a message to Zimmer Biomet and other companies who willingly look the other way in order to increase their bottom-line.
In the case of the Reverse Shoulder Recall, Zimmer Biomet cannot afford to look the other way. They need to support people who trusted their labelling.