[UPDATE] FDA RECALLS ZIMMER-BIOMET COMPREHENSIVE REVERSE SHOULDER IMPLANT
FDA announces Class I Recall of Zimmer-Biomet Comprehensive Reverse Shoulder Implant due to High Fracture Rate
Feb. 15, 2017 — The FDA announced a Class I Recall of the Comprehensive Reverse Shoulder Humeral Tray (Model 115340) because the devices are fracturing at a higher rate than stated in the labeling.
If an implant fractures, patients may need additional surgery to remove or replace it. Revision surgeries put patients at increased risk for:
- permanent loss of shoulder function
Zimmer-Biomet initiated the recall of its Comprehensive Reverse Shoulder Implant on Dec. 20, 2016 when it sent an Urgent Medical Device Recall Notice to affected customers. The recall notice advised those customers (i.e. physicians, healthcare facilities, etc.) not to use the recalled devices and said its sales reps would be by to remove them.
FDA classified this recall as a class I — the most serious type of recall because there is a “reasonable probability” that the device will cause serious adverse health problems or death.
Zimmer-Biomet said doctors should monitor patients implanted with the recalled device as usual and provided no additional patient monitoring instructions.
About 3,662 implants were affected by the recall.
To view the full FDA Class I Recall and to see a list of affected lot numbers, visit the FDA’s website.
Do You Qualify? – Biomet Comprehensive Shoulder Implant Lawsuits
Did you suffer serious complications after having a Biomet Comprehensive Reverse Shoulder System implanted?
Biomet recalled some of its Comprehensive shoulder replacement implants in 2010 after receiving complaints from patients and doctors about the device fracturing after surgery.
If you or someone you love was injured as a result of complications from Biomet’s Comprehensive Reverse Total Shoulder System, you may be entitled to compensation. Contact our lawyers and attorneys today as there may be a class action lawsuit forming with substantial cash settlements from claims filed.
Call the experienced lawyers at National Injury Help today for a free consultation to see if you qualify for a Biomet Comprehensive Lawsuit.
Call 1-800-214-1010 at any time for a free case evaluation or use the form on the right-hand side of your screen.
Biomet Comprehensive Shoulder Implant Complications
Medical device manufacturer Biomet Inc. (now Zimmer-Biomet) boasted that its Comprehensive Reverse Shoulder System would be the “next generation reverse shoulder prosthesis.”
The Comprehensive device was approved for use in 2007 under the U.S. Food and Drug Administration’s 510(k) premarket program. This meant Biomet only had to show that its new device was “substantially similar” to others currently on the market, bypassing the need to submit rigorous clinical safety and efficacy studies for approval.
Just a few short years after the device was approved by the FDA, Biomet recalled components of its shoulder implant system, citing complaints from patients and doctors about device fracturing.
Over 50,000 Americans undergo shoulder replacement surgery each year to relieve joint pain. There are several types of shoulder replacement surgery, including conventional and reverse shoulder replacement.
Reverse shoulder replacement is performed in patients who have completely torn rotator cuffs or previously failed replacement surgeries. Reverse implants rely on different muscles to move the arm than traditional implants and can help restore some motion to these patients who have lost mobility in their shoulders due to severe pain.
While the vast majority of shoulder replacement surgeries are successful, some patients implanted with Biomet’s Comprehensive Reverse Shoulder System found that their surgeries were anything but successful.
The Comprehensive Reverse Shoulder System has been blamed for painful complications, including:
- bone loss
- device fracture
- device failure
- need for additional surgeries
Individuals harmed by the Comprehensive Reverse Shoulder System may be able to seek settlements in the form of a Biomet Comprehensive Lawsuit.
Comprehensive System Recall
[UPDATE] The FDA announced a class I recall of Zimmer-Biomet’s Comprehensive Reverse Shoulder Implant on Feb. 15, 2017. See the FDA’s announcement for more information.
Merely three years after Biomet’s Comprehensive reverse shoulder hit the market, the company initiated a recall of certain components of the system.
In a September 2010 Urgent Medical Device Recall Notice, Biomet said it was pulling at least 45 humeral tray and 45 locking ring components in distribution in eight states. The company said it initiated the recall after receiving complaints that the device was fracturing after being implanted.
The FDA posted the recall in December 2010 and labeled it as class II, meaning use of the device could cause temporary or reversible adverse health consequences. The agency terminated the recall in July 2011, but the FDA-determined cause remains pending on the agency’s website.
The humeral tray and locking ring components were recalled from at least eight states in the U.S., including New York, Virginia, Maryland, Alabama, Colorado, South Dakota, Texas and Oklahoma.
Biomet Settles Comprehensive Lawsuit for $350,000
Biomet agreed to settle a lawsuit involving its Comprehensive Reverse Shoulder System for $350,000 in February 2016.
The lawsuit was filed in the U.S. District Court for the District of Colorado by a man who was implanted with two Biomet Comprehensive systems. The devices later fractured and the man had to undergo additional surgeries to remove and replace the failed systems.
The plaintiff sued Biomet for product liability in 2014, and the company agreed to settle those allegations roughly two years later in February 2016.
Biomet Comprehensive Shoulder Implant Lawsuit
Patients harmed by Biomet’s Comprehensive Reverse Shoulder System may be able to seek compensation for medical expenses, wages lost and other damages in the form of a Biomet Comprehensive Lawsuit.
National Injury Help is currently investigating cases for a potential lawsuit against the makers of the Comprehensive system, Biomet Inc., now Zimmer-Biomet. If you or someone you love suffered complications like device failure or a need for additional surgeries after being implanted with a Comprehensive device, call the National Injury Help today to speak with a member of our legal team. We can answer your questions and help you determine if your case qualifies for a possible Biomet Comprehensive Lawsuit.
Call National Injury Help anytime, day or night, at 1-800-214-1010 or use the form on the right-hand side of your screen.
Biomet lawsuit claims and settlements page updated on 4/5/2019