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Zimmer Biomet Reverse Shoulder Lawsuit states the manufacturer of this medical device was negligent in its design, which is experiencing a high failure rate and the need for revision surgery. – Do you or someone close to you have complications related to a Zimmer Biomet Reverse Shoulder? You’re not the only one who has experienced complications. This device has caused thousands of people pain, financial stress, and suffering. 

The Justice Now provide you Free Case Evaluation opportunity to Sue the Zimmer Biomet and Get Compensation for all the suffering you and your family went through. Fill this form and you will receive a call from our Experts ASAP >

For those who suffer extreme joint pain or a limited range of shoulder motion, a popular corrective solution is shoulder replacement surgery. Those with debilitating shoulder injuries that more conservative methods cannot treat often turn to the use of a shoulder replacement device for relief, based upon promises of increased function and minimized pain. However, when patients are implanted with a faulty replacement device, it can result in exacerbated pain, rising medical expenses, and the need for corrective surgery. Recently, replacement devices have been alleged to cause additional injuries in patients, including significant bone loss, instability, weakness, and unexplained pain.

Undergoing revision surgery because of a faulty shoulder replacement device is burdensome for doctors and patients, who must now face the task of addressing additional complications brought on by the defective device. At The Justice Now, our lawyers fight for those who have fallen victim to a flawed shoulder replacement device that has caused additional injury or necessitated corrective surgery.

Fractured Components Lead to Zimmer Biomet Recall

In December 2016, Zimmer Biomet recalled 3,662 reverse shoulder components of its Comprehensive model line. It was one of the most extensive recalls of reverse shoulder devices in recent years.

In the recall notice, Zimmer Biomet said its Comprehensive Reverse Shoulder System Humeral Tray Model 115340 suffered a high fracture rate. Recalled units had been manufactured between August 2008 and September 2011. Trays manufactured after that time incorporated design changes to prevent fractures.

The affected trays were distributed as late as September 2015.

The U.S. Food and Drug Administration categorized the action as a Class I recall, the agency’s most serious type.

In an Urgent Field Safety Notice, the company warned that fractures could require patients to undergo revision surgery, which could cause serious health complications, including infection, loss of shoulder function and death.

Zimmer Biomet said immediate health risks were not likely, but the devices posed long-term risks. The most likely and most severe risk was that people implanted with the affected models would need revision surgery sometime in the future if the component fractured.

Faulty Replacement Devices

Patients and doctors note that defectively designed shoulder replacement products have led to the devices failing soon after being implanted, rather than the advertised corrective solution to shoulder pain. In some instances, the metal-on-metal design of some replacement devices has led to metal poisoning, bone and tissue damage, and implantation failure. Ineffectual surgical reconstruction of a joint or body part can manifest in many ways, including:

  • Metal toxicity released into the body
  • Bone and tissue damage
  • Component erosion
  • Dislocation or insecurity of replacement device due to faulty design

Correcting the damage of a poorly designed replacement device may require revision surgery, additional treatment, and removing the implant altogether.

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What is the Purpose of a Reverse Shoulder Implant?

A conventional shoulder replacement implant is designed to replicate the normal anatomy of a shoulder. In a reverse shoulder replacement, the design is reversed to be exactly opposite to a person’s natural anatomy.

The reverse total shoulder replacement works better than conventional shoulder implants for people with cuff tear arthropathy because it relies on different muscles to move the arm. Specifically, the reverse shoulder replacement depends on the deltoid power, instead of the rotator cuff, to stabilize and operate the arm. This type of surgery has become the third largest market in joint reconstruction, primarily driven by the ageing population and increasing levels of obesity.

The Zimmer Biomet Reverse Shoulder received FDA approval in 2008 through the controversial 510(k) Pre-Market Approval process, which allows manufacturers to bring products to market if they can show the products are “substantially similar” to an existing product already being sold and distributed.

The Zimmer Biomet Recall

On December 15, 2016, Zimmer Biomet issued a voluntary recall of its 3,662 Comprehensive Reverse Shoulder Humeral implants distributed during the 2008 – 2015 period. The company has asked healthcare providers to remove all recalled implants from their shelves and return them to the company.

The FDA has identified this recall as a Class 1 recall, meaning the faulty implants can potentially cause severe injury or even death.

This is not the first time there have been problems with Zimmer’s Reverse Shoulder System. 2010, the FDA issued a recall for the Comprehensive Reverse Shoulder Humeral Tray with Locking Ring. In 2015, the Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm was recalled with a Taper Adaptor.

Other recalls of reverse shoulder devices between 2010 and 2016 had been more minor. While different companies had recalled devices, for the most part, the number of actual units affected had been small.

Timeline of Manufacturers and their Recalled Devices

  • Manufacturer/Device - Biomet (later Zimmer Biomet) Complete Reverse Shoulder Humeral Tray with a 49mm Locking Ring
  • Units Recalled- 47
  • Recall Reason- Several reports of the device breaking

Complete-Reverse-Shoulder-Tray

  • Manufacturer/Device - Encore Medical RSP Humeral Socket Shell
  • Units Recalled - 81
  • Recall Reason - The device was able to fail to correctly connect with the stem that is attached to the bone of the arm.

Encore-Medical-RSP-Humeral-Socket-Shell

  • Manufacturer/Device - Integra Titan Reverse Shoulder, right as well as left cut templates
  • Units Recalled - 12
  • Recall Reason - Template for cutting bone bent backwards and welded, which resulted in a wrong angle.

Integra-Titan-Reverse-Shoulder

  • Manufacturer/Device - Zimmer Biomet size 25mm Glenosphere Small Baseplates for the Comprehensive system
  • Units Recalled - 11
  • Recall Reason - Taper adaptor not included in a package, causing surgery to be delayed by longer than thirty minutes.

Zimmer-Biomet-size-25mm-Glenosphere-Small-Baseplate

  • Manufacturer/Device - Tornier (Wright Medical) Aeuqalis Fx2 shoulder implants that are both reverse and traditional configurations.
  • Units Recalled - 30
  • Recall Reason- Reports of dislocations.

Tornier-(Wright-Medical)-Aeuqalis-Fx2-shoulder-implants

  • Manufacturer/Device - Zimmer Biomet Comprehensive Humeral stems
  • Units Recalled - 12
  • Recall Reason - The two lots were mixed in manufacturing and etched with the wrong lot numbers. The size differences between the two sizes of stems amount to 1.1 inches.

Zimmer-Biomet-Comprehensive-Humeral-stems

  • Manufacturer/Device - Zimmer Biomet Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System
  • Units Recalled - 16
  • Recall Reason -  The two pieces of the lot were transferred to finished goods before being shipped even though they had an unconfirmed Non-Conformance Report (NCR). The NCR revealed that one item of the lot had scratches and non-conforming threads.

Zimmer-Biomet-Modular-Hybrid-Glenoid-Base-Large

The FDA has classified these recalls as Class 2 – which means that it is believed that the product “may cause temporary or medically reversible adverse health consequences” or in cases where there is a high risk of severe health hazards.

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Zimmer Biomet and a History of Settlements

In 2014, the device giant settled the first lawsuit outside of court regarding defective shoulder replacements for $350,000. Zimmer Biomet refused to admit fault in this settlement. This is not Zimmer Biomet’s first time in legal trouble for producing a faulty product.

In 2012 alone, the manufacturer paid close to $56 million to settle lawsuits against their flawed products. Since 2003, Zimmer has been forced to recall 75 components of their knee replacement hardware. Even with a decades-long record of development recalls and lawsuits, Zimmer Biomet generates billions of dollars in profit each year.

Colorado Man Files Lawsuit After Devices Fail

Alfonso Alarid of Denver, Colorado, received a Comprehensive Shoulder System to replace his left shoulder in September 2009. He received another Comprehensive implant to return his right shoulder in July 2010.

While undergoing physical therapy in 2012, the humeral tray separated from the stem in his left shoulder, and Alarid had to have the implant replaced. In March 2013, the implant in his right shoulder failed similarly, and it, too, had to be replaced.

Both devices were among the 47 Comprehensive Reverse Shoulder systems affected by Biomet’s September 2010 recall.

Alarid filed a lawsuit in state court in Colorado against Biomet in July 2014 before the company merged with Zimmer.

In his complaint, Alarid claimed that Biomet had received multiple reports of problems with the device. He also claimed Biomet had sold implants in “defective and unreasonably dangerous condition” that resulted in his injuries requiring two revision surgeries.

The case was moved to federal court in Denver in September 2015.

In February 2016, Biomet, a part of Zimmer Biomet, agreed to pay Alarid $350,000 to settle the claims against the company.

Do you have a Zimmer Biomet lawsuit?

The use of replacement devices to remedy painful shoulder symptoms was popularized following manufacturers’ promise of comfort, mobility, and simplicity. However, the implantation of a faulty replacement device can result in worsened injury that leaves the patient with debilitating pain and costly medical bills for years to come. At The Justice Now, our attorneys believe that the compounded pain and suffering that patients must undergo to correct post-surgical injuries caused by poorly designed implants is inexcusable.

To learn how our medical device injury lawyers can help you and your family, don’t hesitate to contact us for a Free Case Evaluation. You can fill the form given on this page to apply for evaluation right now. We would be honoured to speak with you and will respond promptly to every inquiry we receive.

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