Zimmer Biomet Reverse Shoulder

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.

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.

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.