Zimmer Biomet is the second-largest medical device manufacturer in the world, each year selling more than 1 million artificial knee, shoulder, hip, ankle, foot and elbow implants. The company has over $4.5 billion in annual sales.
On December 20th, Zimmer instituted a Class I recall of one of its most popular shoulder implant devices, the Comprehensive Reverse Shoulder. This device reverses the normal anatomy of the shoulder, putting the ball on the shoulder blade and socket on the upper arm, in order to allow the deltoid muscle to control the arm.
The Zimmer shoulder device used in some of the most severely effected patients, including those who’ve developed arthopathy shoulder arthritis and those who have already had a failed shoulder replacement surgery.
The recall was made after the Zimmer Biomet shoulder implant was found to fracture at higher rates than expected. These fractures may cause device breakage, separation, severe pain, the loss of shoulder function, need for replacement surgery, infection or even death.
According to the FDA, Class I recalls are for devices that have a “reasonable probability’ of causing “serious adverse health consequences or death.”
However, in their recall, Zimmer only notified doctors, hospital staff and administrators of the danger. No patients were notified and doctors were instructed that increased patient monitoring was not necessary.
Also, Zimmer Biomet had knowledge of the potential for device fractures as early as 2010, when a prior recall was issued on the same product. However, they continued to sell the defective shoulder implants for several years.
Based on Zimmer’s sale of a dangerous product, and their failure to properly warn patients about the risks, they are liable to those affected. Lawyers are currently helping those with defective shoulder implants file lawsuits.
The Zimmer Biomet Shoulder Recall affects implants distributed between October 2008 and September 2015, which could have been used in implants up to the date of the recall.
Anyone who underwent shoulder replacement or implant surgery from 2008 through December of 2016 and received a Zimmer Biomet implant should learn if their device is included. Those who received the defective devices are eligible to file a claim.
A lawyer can review your medical records and determine if you are eligible at no cost. Simply contact DrugNews to speak with a lawyer today.
At this time there is not a consolidated Zimmer Biomet shoulder class action lawsuit. However, lawyers are filing individual cases against the manufacturer in several different federal court districts. Since the recall affects several thousand patients, a large number of claims are expected.
Due to the expected volume of cases, they will likely be consolidated into a centralized federal multidistrict litigation (MDL) court for expedited handling. MDL courts offer the advantages of a class action case, however, victims have more control over their case.
For example, they can select their own lawyer rather than joining a group, and they can decide whether or not to settle their case. Also, MDL cases usually result in greater awards to victims than class action lawsuits.
As with all lawsuits, the value of each Zimmer shoulder claim is unique, depending on several factors like the age of the patient, the degree of device failure or side effects, and whether the patient needs revision surgery.
In 2016, Zimmer paid $350,000 to settle one of the first lawsuits filed over a faulty shoulder device. Based on the severe complications, need for invasive repeat surgery and painful rehab required in many of these cases, lawyers expect lawsuits will seek compensation into the hundreds of thousands of dollars or more.
It takes only a few minutes to contact DrugNews and you can speak with a lawyer today at no cost. They can review and qualify your case for further investigation that same day.
After you retain a lawyer, they will gather essential records about your surgery and the specific device used before filing a formal lawsuit. It can take a year or more to prepare your case for trial or settlement. However, it is very unlikely that you will have to travel anywhere and it costs you nothing unless you receive compensation.
This case, filed in 2014 by Mr. Alfonse Alarid from Colorado, is believed to be the first lawsuit against Zimmer Biomet over a defective Comprehensive Reverse Shoulder device. Mr. Alfonse alleged he had suffered the failure of two different shoulder devices, causing the need for painful revision surgeries.
Mr. Alarid’s shoulder implants were part of a prior recall that occurred in 2010 for similar fracturing issues. Just before the date his lawsuit was scheduled to go to trial in February of 2016, Zimmer Biomet agreed to pay a settlement of $350,000.
On December 8, 2016, the Department of Justice announced a revised settlement with Zimmer Biomet over allegations that Biomet bribed government-run healthcare providers in Argentina, Mexico, Brazil and China for help in securing sales of its shoulder, hip and knee devices.
The case had originally been settled in 2012, however, Biomet admitted to additional misconduct in Mexico and Brazil in 2015. Investigators found that medical device manufacturers like Biomet would pay bribes to foreign officials that were masked as scientific incentives, commissions, royalties, and consulting fees in company records.
Zimmer Biomet has agreed to pay $17.3 million in criminal penalties, as well as a civil settlement of $5.4 million to the U.S. Securities and Exchange Commission. They also agreed to maintain a compliance program to prevent future misconduct.
The FDA labels Zimmer’s latest shoulder recall as a Class I, the most serious designation for devices that have a “reasonable probability’ of causing serious adverse health consequences or death.
Zimmer Biomet issues “Urgent Medical Device Recall Notice” to doctors, hospitals and providers due to higher risk of shoulder device fracture, which can cause device breakage, separation, severe pain, loss of shoulder function, replacement surgery, infection or death.
Zimmer Biomet pays $350,000 to settle the first lawsuit filed as a result of fractures in the Comprehensive Reverse Shoulder system.
Zimmer Orthopedics pays $14 million to acquire Biomet, creating Zimmer Biomet, the second largest medical device manufacturer in the world.
The first lawsuit alleging injury from a fractured Biomet Comprehensive Reverse Shoulder implant is filed by a Colorado man, who underwent revision surgeries after two different devices fractured.
Second recall of more than 57 lots of Biomet Comprehensive Reverse Shoulder implants issued over defective locking rings.
Biomet issues first recall of 8 lots of the Comprehensive Reverse Shoulder system after they are found to have higher risks of fracture. Recall letters advise doctors to monitor patients for signs of device fracture, but does not notify the public.
The FDA approves sale of the Biomet Comprehensive Reverse Shoulder in the United States under 510(K) protocols, which do not require safety trials since the product is substantially equivalent to a previously approved product.
If you or a loved one underwent shoulder replacement surgery with a Zimmer Biomet implant since 2008, it is important to learn your legal rights. These devices have been recalled due to health risks and lawyers are now pursuing lawsuits against the manufacturer due to their failure to properly warn patients.
Zimmer Biomet has issued three recalls of the Comprehensive Reverse Shoulder implant, due to risks of fracture or defective locking rings. Fractured devices can require painful removal surgery, as well as infection, permanent loss of shoulder function, or death.
If you are contacted by Zimmer Biomet or their representative about the shoulder recall, it is important that you DO NOT SIGN anything before first speaking with a lawyer.
Choosing the right lawyer may also significantly affect your case. Defective medical device injury lawsuits are usually filed in special federal multidistrict courts, not in your local court. Therefore, it is recommended that you choose a lawyer with extensive experience in these cases, rather than a local attorney.
The right law firm will offer to meet with you at your home, take care of gathering all necessary medical records, and appear at all necessary events on your behalf, so you never have to leave home or appear in court.
DrugNews works only with law firms that specialize in medical device and pharmaceutical injury lawsuits, and have handled thousands of these cases across the country. Contact us today to speak with a lawyer at no charge.