Did You Suffer Injury After Being Implanted with a Zimmer Biomet Shoulder Replacement?
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WARNING: Reverse Shoulder Replacement Recipients – FDA Class 1 Recall for Biomet Comprehensive RS Shoulder System
February 16,2017: The United States Food and Drug Administration has issued a Class 1 recall of all Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115340. The agency issued this, the most serious of all recall types, after determining that use of the reverse shoulder system can cause serious injury and death.
About the Recall
All lot numbers of the Biomet Comprehensive Reverse Shoulder Humeral, product code KWS, PAO have been recalled with the part number 115340. These devices were manufactured between August 25, 2008, and September 27, 2011, and were distributed across the U.S. from October 2008 to September 2015.
The device is being recalled they are fracturing at a higher rate than the agency was previously made aware. These device fractures can cause serious problems and force the patient to undergo risky revision surgery. These surgeries are performed when a replacement device needs to be repaired, removed, or replaced because of failures. These additional surgeries can have serious consequences on a patient’s health including permanent loss of the use of the shoulder, infection, and even death.
For some, the risks of these additional surgeries are too great, leaving patients with defective implants, while for others the damage caused to local tissue and bone may prevent a patient from being a revision candidate.
About the Biomet Comprehensive Reverse Shoulder
Reverse shoulder replacements are designed for patients who are suffering pain and limited range of movement of their shoulder joint because of severe rotator cuff tears and damage. The device is designed so that the ball and socket of the shoulder joint are reversed with the ball of the joint being implanted to the shoulder socket of the scapula and the socket of the joint is implanted at the top of the humerus (arm bone). This system relies on the deltoid muscle group to hold the joint in position.
The surgery to implant this type of device is highly technical, and the devices used in this type of procedure can cause serious complications if the components wear, dislocate, or loosen. In these cases, the patients must be re-operated on so the device can be repaired, replaced, or removed.
In December 2016, Biomet issued an Urgent Medical Device Recall Notice to all surgeons and facilities that have the Comprehensive RS Shoulder Implant asking them to identify and quarantine any devices they have so they can be shipped back to the manufacturer. However, the company did not provide any type of specific monitoring instructions to patients who want to protect themselves from further shoulder damage.
Patients who have experienced adverse events with the Biomet Comprehensive Reverse Shoulder System may be eligible to seek compensation for the injuries they have sustained from this device. If you or a loved one were implanted with the Biomet Comprehensive Reverse Shoulder System Model 115340, contact us now to learn about the options that may be available to you, including significant financial compensation.