Over 3,600 Zimmer Biomet shoulder replacements sold from 2008-2015 were recalled due to the risk of fracture, failure, infection, surgery, and even death. In 2016, the first lawsuit ended in a $350,000 settlement.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Zimmer Biomet Reverse Shoulder Replacement injury cases in all 50 states. If you or somebody you know has a recalled shoulder implant that failed or needed surgery, contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Zimmer Biomet Shoulder Recall
February 2017 — Zimmer Biomet Composite Reverse Shoulder Humeral Trays were recalled due to a higher-than-expected rate of fractures and revision surgery.
Complications & Health Risks
Reverse shoulder replacements that fracture will need another surgery to replace the broken implant. The patient’s arm bone will also need to be shortened. This can lead to devastating complications like infections, permanent loss of shoulder function, disability, or death.
$350,000 Shoulder Lawsuit Settlement
Biomet Inc. paid a $350,000 settlement in a shoulder replacement lawsuit in February 2016. The lawsuit was filed by a person who was implanted with two Comprehensive Reverse Shoulders in 2009 and 2010. Both implants were recalled in 2010, and both eventually fractured at the baseplate — Case No. 14-02667.
Class II Recalls: Biomet Reverse Shoulder
- In April 2011, Biomet recalled about 1,575 of the Custom Comprehensive Reverse Shoulders because they may contain a locking ring that is incorrectly assembled.
- In September 2010, Biomet recalled about 45 of the Comprehensive Reverse Shoulders due to fractures between the trunnion and baseplate.
Urgent Safety Warning
In December 2016, Zimmer Biomet issued an “Urgent Medical Device” safety warning (PDF) about the risk of fractures with Comprehensive Reverse Shoulder replacements made before September 2011. The company said shoulder implants made after September 2011 have “design enhancements that increase the strength of the device.”
What Shoulder Replacements Were Recalled?
The Zimmer Biomet Comprehensive® Reverse Shoulder is a medical device that is used in “reverse shoulder” replacement surgery. It is designed to help patients who have a torn rotator cuff and a severe type of arthritis known as arthropathy or “Charcot Shoulder.”
Product Information
The recall involves 3,662 shoulder implants that were sold from October 2008 through September 2015. For more information:
- Manufacturing Dates: August 25, 2008 to September 27, 2011
- Product Codes: KWS, PAO
- All Lots With Part #115340
- See a full list of recalled lots
What is Reverse Shoulder Surgery?
Reverse shoulder surgery switches the shoulder’s normal “ball-and-socket” design by attaching a metal ball to the socket (glenoid) and a plastic cup to the end of the arm bone (humerus). This helps people with rotator cuff tears by allowing the deltoid muscle to move the arm.
Unique Problems of Reverse Shoulders
The the first reverse shoulder implants were approved in 2004, so there is very little information on long-term safety. Experts have discovered many unique hazards and high rates of loosening, instability, fracture, infection, nerve damage, and hematoma.
Infected Shoulder Implants
Studies show that infections occur in up to 10% of reverse shoulder surgeries. When antibiotics fail to cure the infection, patients will need a procedure to irrigate the joint with saline and scrape out the infection. They may also need to have the plastic liner replaced.
Fractured Shoulder Implants
One serious ongoing issue with reverse shoulder implants is fracturing of the baseplate or “humeral tray.” It usually occurs when the implant baseplate loosens or fails to attach to the patient’s bone. The use of locking screws has reduced fracture rates.
Do I have a Zimmer Biomet Shoulder Lawsuit?
The Schmidt Firm, PLLC is currently accepting Zimmer Biomet Reverse Shoulder Replacement injury cases in all 50 states. If you or somebody you know has a recalled shoulder implant that failed or needed surgery, contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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