Zimmer Biomet Reverse Shoulder

Patients who had a Zimmer-Biomet Reverse Shoulder implant are filing litigations after the device was associated with high failure rates and serious injuries. According to the attorneys who are currently pursuing the cases, the manufacturer negligently designed the shoulder implants, leading to a mounting number of bone fractures and corrective surgery operations. Although the device was intended to restore the range of motion in patients who did not respond well to traditional shoulder replacement, the company allegedly concealed the higher than expected rate of failed surgeries.

Device Type:  Shoulder Implant

Injury:  Bone Fractures, Death

Manufacturer: Zimmer Biomet

Total Cases: 2700

Settlement Amounts: EST – $400,000 over $1,000,000

Bellwether Trial Start Date:        April 2017

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What is a Zimmer Reverse Shoulder Implant?

When in 2008 the Food and Drug Administration (FDA) approved it through the controversial 510(k) Pre-Market Approval process, the Zimmer-Biomet Comprehensive Reverse Shoulder seemed to be a technology marvel. Unlike the original corrective implants used up to that point, the one manufactured by Z-B used a design that replicated the exact reverse of person’s natural shoulder anatomy.

In theory, this reversed design was supposed to work better than conventional shoulder implants, particularly for those who suffered from a serious form of arthritis known as “cuff tear arthropathy”. Since the new implant relied on a different shoulder muscle, the deltoid one, it helped stabilize the arm without imposing additional strain on the rotator cuff after replacement surgery.

Why is this device dangerous?

The number of patients who suffered from fractures or require revision surgery shortly after being implanted with the Biomet shoulder device rose at an alarming rate over the course of the last few years. According to court documents, the manufacturer knew about this risk, but failed to disclose this information to the public. Lawyers want to hold the company responsible for this objectionable in court and are seeking financial compensations for the victims of these injuries.

It is not uncommon for a patient suffering from device failure to end up losing the use of his shoulder or, in the most extreme cases even die as a consequence of this hazardous adverse reaction. Researchers found that patients who experienced a fracture after a shoulder replacement surgery had a substantially higher risk of suffering from the fatal consequences of cardiac, pulmonary or abdominal complications. Evidence found in a study published in May 2016 in the Journal of Shoulder and Elbow Surgery indicates that this risk can be up to six times higher than in general population.

The FDA issues a Zimmer shoulder implant recall

On December 20, 2016, Zimmer-Biomet voluntarily recalled 3,622 Comprehensive Reverse Shoulder System Humeral Tray Model 115340.  The company requested to remove all those devices from their facilities, and recalled all of them which were distributed between October 2008 and September 2015.

The manufacturer issued the recall after the adverse reaction reports submitted by patients to the FDA showed a disturbingly high amount of fractures. According to the regulatory agency, these injuries lead to significant pain, distress, injuries and, in some instances, even death.The FDA identified this procedure as a Class 1 recall due to the severity of the potential damage inflicted by implant failure.

Many people had to permanently lose their arm movement capabilities after the device suddenly snapped during everyday activities. A high number of these unfortunate victims have already been forced to file a lawsuit to face the burden of medical expenses and loss of work caused by the necessity of undergoing major revision procedures.

Zimmer’s Reverse Shoulder Systems have been the target of an FDA recall three times already. Back in 2010 and 2015, regulators requested the Comprehensive Reverse Shoulder Humeral Tray with Locking Ring and the Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor to be withdrawn from the marked because of their dangerousness.

Current state of the Biomet Shoulder Implant litigation

On February 2016, Biomet settled a litigation from a plaintiff who suffered several grievous injuries caused by the consequences of two Comprehensive Reverse Shoulders failed implants in 2009 and 2010. According to the lawsuit filed in the U.S. District Court, District of Colorado (Case No. 14-02667) on July 20, 2014, the man had to undergo revision surgeries two times in 2012 and 2013. Accused of negligence, breach of express warranty and strict products liability, the medical device company eventually paid the man $350,000 to settle the case.

To date, judges did not consolidate the many shoulder replacement lawsuits filed in court into a single Multidistrict Litigation (MDL). However, if a substantial number of cases are brought to the attention of federal and state courts, it is just a matter of time before centralization occurs.