Alert!!! FDA Recalls Zimmer-Biomet Comprehensive Reverse Shoulder Implant!
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Zimmer-Biomet comprehensive shoulder Implant lawsuit

Zimmer-Biomet shoulder recall

Tens of thousands of Americans undergo shoulder replacement surgery each year to relieve joint pain. One type of shoulder surgery is known as ‘reverse shoulder replacement’. Reverse shoulder replacement may be performed in patients who have completely torn rotator cuffs who then developed a severe type of shoulder arthritis known as arthropathy. Reverse shoulder replacement is also performed on those who previously failed shoulder joint replacement.

Reverse shoulder replacement is a surgical procedure that reverses the normal anatomy of the shoulder. By doing so, the deltoid muscle, one of the stronger shoulder muscles (and the only abducting muscle remaining in the shoulder), is given control to raise the arm. Thus, the idea is that a reverse shoulder implant will help restore motion to patients who have lost mobility in their shoulders.

No doubt in an effort to capture market share, medical device manufacturer Biomet (now Zimmer-Biomet) boasted that its Comprehensive Reverse Shoulder System would be the “next generation reverse shoulder prosthesis”.

However, on February 15, 2017, the FDA announced a class I recall of Zimmer-Biomet’s Comprehensive Reverse Shoulder Implant. A class I recall is the most serious type of recall because there is a “reasonable probability” that the device will cause serious adverse health problems or death. The stated reason for this recall was the Comprehensive Reverse Shoulder fracture at a higher rate than stated in the labeling. If an implant fractures, patients may need a revision surgery to remove or replace it. If a patient has to endure a revision surgery, there is an increased chance of permanent loss of shoulder function, infection and even death.

As a result of this recall, the attorneys at TheLawFirm.com are now actively investigating the possibility of filing lawsuits regarding the Zimmer-Biomet Comprehensive Reverse Shoulder. Patients harmed by the Comprehensive Reverse Shoulder System may be able to seek compensation in the form of a Biomet Comprehensive Reverse Shoulder lawsuit.

Biomet has already settled a lawsuit for it's comprehensive reverse shoulder system

The lawyers at TheLawFirm.com have learned that Biomet has already settled a lawsuit involving its Comprehensive Reverse Shoulder System. In Alarid v. Biomet, Inc., et al., the plaintiff underwent a left reverse shoulder replacement with Biomet’s Comprehensive Reverse Shoulder in September 2009. The same device was implanted in his right shoulder in 2010. However, within just a few years of implantation, both shoulders failed, causing pain and loss of function. As a result, the plaintiff was forced to undergo revision surgery to remove and replace the devices.

The lawsuit was scheduled to go to trial in the District of Colorado in February 2016. But the lawyers at TheLawFirm.com have learned that the case settled for $350,000. Every case is different but the lawyers at TheLawFirm.com believe that this amount reflects the serious pain and injury caused by the Zimmer-Biomet Comprehensive Reverse Shoulder System.

The attorneys at TheLawFirm.com expect many more claims to be filed. The Comprehensive Reverse Shoulder System has been blamed for painful complications, including:
• Bone loss;
• Device failure;
• The need for additional revision surgeries;
• Device fracture and
• Malpositioning.
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Zimmer-biomet shoulder recall

The Biomet Comprehensive Reverse Shoulder device was approved for use in 2007 under the U.S. Food and Drug Administration’s controversial 510(k) premarket program. This meant Biomet only had to show that its new device was “substantially similar” to others currently on the market. This process allows the manufacturer to bypass the need to submit rigorous clinical safety and efficacy studies for FDA approval..

As TheLawFirm.com has seen time after time when the 510(k) program is used, the manufacturer was forced to recall a faulty product. 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. About 3,662 implants were affected by the recall.

This recall notice alerted doctors and healthcare facilities that the Comprehensive Reverse Shoulder should not be used and that existing devices would be collected and removed by Zimmer-Biomet.

Zimmer-Biomet said doctors should continue to monitor patients implanted with the recalled device but provided no additional patient monitoring instructions..
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If you or a loved one was injured as a result of complications such as device failure or the need for additional surgery after a Biomet Comprehensive Reverse Shoulder System was implanted, you may be entitled to compensation.  Contact the lawyers at TheLawFirm.com today to discuss your claim. TheLawFirm.com expects to file lawsuits on behalf of those injured or killed by the complications arising from the Zimmer-Biomet Comprehensive Reverse Shoulder.

Client Story:
The attorneys at TheLawFirm.com have already learned stories about problems caused by the Zimmer Comprehensive Reverse Shoulder device. We thought we would share a typical story with you. There are no names of course but this story of fracturing and pain will sound horribly familiar to those of you with this defective device.

Mr. X was happy with his first replacement shoulder. Before the surgery his right arm was painful and useless. He had a Zimmer-Biomet Comprehensive Reverse Shoulder Device implanted and the arm regained movement and he could sleep without pain.

Mr. X reported that, once the artificial shoulder was in place, “the pain was gone instantly.” He was happy for a time.

However, one night Mr. X got up to use the bathroom and it “just busted”. The pain was overwhelming.

He didn’t know it at the time but the metal replacement shoulder had shattered. Fragments of the fractured metal were now imbedded inside his body. The next morning an X-ray revealed the artificial shoulder had broken into pieces.

The fractured metal shoulder had to be removed and another put in its place. Unfortunately, the surgery was not immediate. The shattered metal shoulder began to release metal fragments into his body and he began to suffer from metallosis or metal blood poisoning.

He finally got a surgery date. But, because of his age and the degree of damage the fractured shoulder caused, the Doctor told him he might not live through the surgery. Although Mr. X did, in fact, live, the surgery had major complications and he ended up staying in the hospital for nine days after the surgery.

For a long time Mr. X was unable to find a lawyer to take his case. The legal community was not aware of the failure rate of the shoulder replacement device or the damages it was causing. However, now that the Zimmer Comprehensive Reverse Shoulder Device has been recalled, the dangers of this defective device are readily apparent.

If you have a story like Mr. X, please call TheLawFirm.com for a free consultation. There is no need to suffer alone. We are now preparing cases to file lawsuits against Zimmer-Biomet for the damages caused by these defective shoulder replacement devices.
Call Now For A Free Consultation: 1-855-464-0808


Call TheLawFirm.com today to speak with a member of our legal team. We can answer your questions and help you determine if your shoulder surgery qualifies for a Biomet Comprehensive Reverse Shoulder lawsuit.
Call Now For A Free Consultation:
1-855-464-0808

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