On February 11, 2017, the Food and Drug Administration (FDA)—the agency in the United States that ensures drugs and medical products are safe to use—issued a recall announcement concerning the Zimmer Biomet Comprehensive Reverse Shoulder Implant Model 115340. Prior to issuing the recall notice, the FDA received reports from numerous patients that the devices were failing prematurely at an unexpectedly high rate.
The FDA has issued like recall notices only in instances in which, in the agency’s view, the affected devices were reasonably likely to cause serious adverse medical complications or even, in severe cases, death. Many patients who received the Zimmer Biomet Comprehensive Reverse Shoulder Implant have required additional shoulder surgeries to replace the defective implant.
Zimmer Biomet Comprehensive Reverse Shoulder Implant Was Intended to HelpThe Zimmer Biomet Comprehensive Reverse Shoulder Implant was designed with the intent to help patients restore normal arm movement. Surgeons have used the device to help patients who have experienced anthroposophy caused by rotator cuff tears. Medical professionals have also employed the device to help patients who suffer from severe shoulder arthritis and those who have suffered a failure of a previous shoulder implant.
During a shoulder implant surgery, surgeons must remove the damaged shoulder joint and replace it with an artificial shoulder joint. The manufacturers of Zimmer shoulder implants require surgeons to implant their devices in a manner that is different from more traditional shoulder replacement devices and procedures. The Zimmer Biomet Comprehensive Reverse Shoulder Implant uses a unique reverse shoulder configuration.
Reverse shoulder configurations are useful for patients who do not meet the qualifications for traditional shoulder replacement procedures. During a reverse shoulder implant surgery, a surgeon screws the artificial shoulder device into the patient’s scapula. The surgeon must affix a screw on and into a very narrow part of a patient’s shoulder blade. The narrowness of the area to which the screw is affixed plays a vital role in the shoulder replacement. If a shoulder replacement device fractures, it may leave a patient with very little or no bone. The surgeons can attach a replacement shoulder implant, but this can prove tricky where a patient has suffered bone loss from multiple procedures.
Patients Claim Zimmer Biomet Comprehensive Reverse Shoulder Implant Causes InjuriesNumerous claimants have alleged that the Zimmer device has caused serious negative side effects. Patients who received the Zimmer Biomet Comprehensive Reverse Shoulder Implant have reported bone fractures, permanent loss of shoulder function, impaired movement of the shoulder joint, and the need for the painful shoulder joint revision surgery. Revision surgery is nearly always more dangerous than an initial shoulder implant surgery. Doctors often cause trauma to the shoulder area while removing a defective shoulder joint and replacing it with a new one. Risks to patients include infections and even death.
Patients Claim Zimmer’s Shoulder Implants Cause FracturingMany patients who received a Zimmer Comprehensive Reverse Shoulder Devices have reported that they suffered shoulder fractures caused by the device. Due to the reports about fractures, Zimmer issued a recall of several reverse shoulder devices that were manufactured between October 2008 and September 2015. Patients who received one of the defective shoulder implant devices should speak to an attorney as soon as possible. If a person does not know what type of shoulder device was implanted in a procedure, one may speak with a surgeon to determine whether the implant was a recalled model.
Some Injured Patients May Not Be Qualified for New Shoulder ImplantsUnfortunately, some patients who need new shoulder implant devices cannot receive them. Many of the patients who received reverse shoulder implants made by Zimmer are unable to receive replacement devices after fracturing of the first device. Surgeons are often unable to find enough bone to which to attach a new shoulder device, and the risk of adverse complications from revision surgeries is high. Some patients are forced to live with a defective shoulder implant. Many suffer from chronic pain, a reduced quality of life, and permanent loss of motor function in the shoulder.
Having to live with a defective shoulder device can also cause severe infections. These infections can cause extreme patient pain throughout the area of the shoulder joint, and they can spread throughout the body. Without proper treatment, these infections can become deadly.
Contact Our Experienced Personal Injury Lawyers for Help With ClaimsThe professionals at Arnold & Smith, PLLC believe that victims of defective medical devices have a right to seek compensation. Our experienced product liability lawyers can help you hold Zimmer accountable for any financial and emotional injuries. Contact our Charlotte product liability law firm today to schedule a free initial consultation.