The Zimmer Biomet Comprehensive Reverse Shoulder Humeral (Zimmer shoulder replacement” for short) is a complex medical device designed to completely replace the shoulder joint.
It was produced from August 25, 2008 to September 27, 2011. The device was surgically implanted in patients with the intention of restoring lost shoulder functionality.
The Zimmer shoulder replacement hardware has caused a host of complications in thousands of patients who underwent the replacement surgery, prompting the Zimmer Biomet to issue an emergency recall on the implanted device. The Food and Drug Administration has encouraged patients and doctors to report additional complications to its MedWatch program.
Zimmer Shoulder Replacement System
Shoulder replacement surgery is a serious procedure performed by a licensed surgeon. Due to the high risk associated with this type of surgery, it is usually recommended only as a final option in treatment.
The following steps have been excerpted directly from the Zimmer Biomet Patient-Caregiver handbook:
- A small tube (intravenous line) is inserted into your unaffected arm. This tube is used to administer antibiotics and other medication during your surgery.
- You’re taken to the operating room and given anesthesia.
- Anesthesia takes effect, and your shoulder is scrubbed and sterilized with a special solution.
- Your shoulder replacement surgery will likely take between one and three hours and begins with an incision over your shoulder to expose the joint.
- Bones are fully visible to the surgeon, and special, precision guides and instruments are used to remove the damaged surfaces and cut the humeral head (ball) and prepare the bone to accept the implant.
- The new implant is inserted.
- If your socket is to be replaced, its damaged surface is smoothed and a new plastic surface is inserted. For a reverse shoulder, the surface is prepared and the “ball” is attached.
- The ball and socket are checked for fit and function.
- When the surgeon is satisfied, the incision is closed and covered with dressings.
- A sterile bandage is applied.
- Your arm is put in a splint and may also be wrapped in an ice pack to help control pain and swelling.
- You’re taken to the recovery room, where you will be closely monitored.
- Anesthesia wears off, and you slowly regain consciousness. A nurse is with you and may encourage you to cough or breathe deeply to help clear your lungs. You’re given pain medication.
- You are fully awake and are taken to your hospital room.
- Your shoulder remains swollen and tender for a few days.
Zimmer Shoulder Replacement Complications
The Zimmer Biomet Comprehensive Reverse Shoulder Humeral procedure and hardware have been linked to serious, life-threatening complications. A Food and Drug Administration device recall notice stated, “Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death.”
Complications associated with Zimmer Shoulder Replacement are:
- Implant Displacement
- Device Fracture
- Periprosthetic Fracture
- Neurologic Injury
- Loss of sensation in arms and hands
Defective Zimmer Shoulder Replacement Recall Information
In December 2016, Zimmer Biomet sent an Urgent Medical Device Recall Notice and a Certificate of Acknowledgement form to all affected customers due to complications with the medical device. The recall covered 3,662 Comprehensive Reverse Shoulder System Humeral Tray Models produced between October 2008 and September, 2015.
Specific device information and lot numbers affected are:
- Product Name: Comprehensive Reverse Shoulder System Humeral Tray Model 115340
- Number of Recalled Products: 3,662
- Distribution Dates: October, 2008 to September, 2015
- Manufacturing Dates: August 25, 2008 to September 27, 2011
- Product Codes: KWS, PAO
- Lot Number: All Lots With Part #115340
Have others experienced Zimmer Shoulder Replacement related loss?
Zimmer Biomet produced over 3,000 shoulder replacement units dating back to 2008. These faulty implants caused life-threatening complications in thousands of patients who were advised to choose Zimmer’s product.
Recipients of the Zimmer Shoulder Replacement have suffered difficulties ranging from broken bones to death. Many of the people affected have filed suit against the device manufacturer, in an attempt to find some accountability for their debilitating injuries.
Zimmer Biomet and a History of Settlements
In 2014, the device giant settled the first lawsuit regarding defective shoulder replacements outside of court to the tune of $350,000. Zimmer Biomet refused to admit fault in this settlement. This is not the first time Zimmer Biomet has found itself in legal trouble for producing a faulty product.
In 2012 alone, the manufacturer paid out close to $56 million to settle lawsuits brought against their flawed products. Since 2003, Zimmer has been forced to recall 75 components of their knee replacement hardware. Even with a decades long record of product recalls and lawsuits, Zimmer Biomet continues to generate billions of dollars in profit each year.
Do you have a Zimmer Biomet lawsuit?
If you or someone you love received a Zimmer shoulder replacement and suffered severe side effects, we would like to speak with you. By filing a Zimmer Biomet lawsuit, you may be entitled to compensation for your injuries.
To learn how our medical device injury lawyers can help you and your family, please contact us for a Free Case Evaluation. We would be honored to speak with you and will respond promptly to every inquiry we receive.