Shoulder replacement devices manufactured by Zimmer Biomet, the second
largest medical device maker in the world, have come under scrutiny for
subjecting patients to risks of serious injury and even death. In February
of 2017, the FDA announced that the recall of Zimmer Biomet Comprehensive
Reverse Shoulder implants would be labeled as a Class 1. Class 1 recalls
are the most serious classification reserved for products that pose a
“reasonable probability” of causing harm.
The Zimmer Biomet shoulder recall affects devices manufactured between
August 2008 and September 2011, and distributed to health care providers
between October 2008 and September 2015. Patients who have undergone shoulder
implant and replacement surgery using a Zimmer Biomet device between 2008
and December 2016 may have received a recalled device.
The recall stems from a number of adverse event reports in which it was
discovered that the device was prone to fracture at higher rates than
anticipated, something that was not stated on the product’s label.
Fractures can cause the shoulder device to break, as well as shoulder
separation, severe pain, loss of shoulder mobility, revision or replacement
surgery, infections, and even death.
Part of the reason behind the device’s increased risks of fractures
and patient harm stem from the fact that it was cleared by the FDA using
the expedited 510(K) process. This expedited process allows certain medical
devices to become available to the public without standard safety testing,
as long as the manufactures can show that the new medical device is similar
to one that has already been approved.
After receiving patient reports of adverse events, Zimmer Biomet issued
a recall of the device in December 2016. Because the device manufacturer
only alerted physicians and hospitals, however, many patients with the
device already implanted may not have been made aware of the recall and
potential dangers. It was also discovered that Zimmer Biomet knew of fracture
risks associated with its shoulder device as early as 2010, yet continued
to sell the product.
Shaheen & Gordon, P.A. is currently reviewing cases from patients who
received a Zimmer Biomet shoulder implant anytime between 2008 and 2016
and experienced injuries, revision surgeries, and other serious complications.
We are also filing lawsuits on behalf of injured victims over the defective
design, manufacturing, and marketing of the device.
Learn more about your right to financial compensation and whether you may
have a case by requesting a consultation with a Maine attorney from our
firm. Shaheen & Gordon, P.A. proudly serves clients throughout Maine,
New Hampshire, and Northern New England.
Contact us today.