In December, medical device giant Zimmer Biomet issued what has become a Class-I recall of one of their most popular shoulder implants, the Comprehensive Reverse Shoulder. However, the company did so without notifying the thousands of patients that had received the devices.
Now, many are questioning the company’s handling of the recall, and asking if Zimmer could have done more to protect patients from potential implant failures and the need for painful revision surgery.
Comprehensive Reverse Shoulder Designed for High Risk Patients
Zimmer is the world’s second-largest medical device manufacturer, with over a million new patients each year using their shoulder, knee, elbow, hip, foot or ankle devices to regain mobility.
Their Comprehensive Reverse Shoulder (CRS) was approved by the FDA in 2008. The device was intended for those with severe shoulder arthritis or who had already undergone a failed shoulder replacement. Using a reverse of the normal shoulder model, it puts the socket on the upper arm and ball on the shoulder blade to allow control with the deltoid muscle.
Two Prior Recalls
Biomet first recalled select models of the CRS implant in 2010, when it was discovered that the device had a high likelihood of fracture. At that time, only doctors were alerted - no patients were notified of the dangers.
Then, in 2011, the company issued a second recall of certain CRS implants over problems with defective locking rings.
Now, with the latest recall instituted on December 20th, Zimmer has warned doctors, hospitals and staff that the CRS implants again pose a risk of fracture or failure. This can lead to shoulder implant breakage, separation, loss of function, infection, death or the need for revision surgery.
Last month, the FDA labeled Zimmer’s Comprehensive Reverse Shoulder recall as a Class I recall. This signifies those defective products that have a “reasonable probability’ of causing serious adverse health consequences or death.”
Patients Not Notified of Recalls
What is shocking, however, is that Zimmer’s recall was targeted solely to medical professionals, with the intent of removing unused CRS implants from the shelves and preventing future use in surgeries. The company didn’t notify any of the thousands of patients who already received the implants that they may be in danger.
Many of those patients are angered by the company’s failure to notify them, especially when records show they knew of possible dangers as early as 2010. Already, many have filed Zimmer shoulder recall lawsuits against the company for their pain, medical treatment and future loss.
Zimmer Already Settling Lawsuits Over Recalled Device
Due to the growing number of these cases, they will likely be consolidated to a special federal multidistrict litigation court (MDL). This is similar to a Zimmer shoulder recall class action lawsuit, however with greater control over individual cases for those involved.
Already, Zimmer paid a reported $350,000 settlement last February for one of the first lawsuits filed over these now-recalled shoulder implants by a Colorado man who had to undergo revision surgeries for his defective device.
Help Still Available
Lawyers say Zimmer is liable to those customers affected by the faulty shoulder implants based on their sale of a dangerous product, and failure to properly warn about the risks. They are currently investigating new cases for those with recalled or defective devices at no cost.
If you or a loved one received a Zimmer Biomet shoulder implant from 2008 to the present and are experiencing problems, it is important to find out if you are affected by the recall. You should also learn whether you are entitled to compensation from a lawsuit.
Contact DrugNews today to learn more, or to speak directly with a lawyer about your case.
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