Numerous complaints by people who have had shoulder replacement implants have spurred the Food and Drug Administration (FDA) to action. The FDA has issued a Class 1 recall for the Zimmer Biomet Comprehensive Reverse Shoulder Humeral. This is the most serious recall issued by FDA. It means that the device may cause serious injuries or death.
What's wrong with the Comprehensive Reverse Shoulder Humeral?
Zimmer Biomet designed the Comprehensive Reverse Shoulder Humeral as advanced shoulder replacement for people who have reduced arm mobility because they have experienced one or more of these problems:
- Suffered a rotator cuff injury
- Suffered from a type of arthritis known as arthropathy
- Have had a previous shoulder joint implant that failed
For these people, other types of shoulder replacement surgery are not an option. Rather, they must have a reverse total shoulder replacement made possible with the Zimmer Biomet implant. This device uses the deltoid muscle to move the arm rather than the rotator cuff.
In an effort to get this product to market as soon as possible, Zimmer Biomet asked for and was granted expedited approval through the 510(K) fast-track program. This program enables medical device manufacturers to forego the usual round of human trials.
Perhaps Zimmer Biomet should have conducted those trials. It now appears that its Comprehensive Reverse Shoulder Humeral is prone to defects. The problem is that device is fracturing at a higher than expected rate. And when it fractures, the patient has to have revision surgery, increasing the possibility of the complete loss of shoulder and arm function, infection, and death.
What you should do
Zimmer Biomet has advised healthcare providers that no patient monitoring action need be taken beyond regular surgical follow up protocol. However, people who have the Comprehensive Reverse Shoulder Humeral implant should be proactive. You should seek a consultation with your doctor if you haven't had one already.
If your Zimmer Biomet Comprehensive Reverse Shoulder Humeral implant has fractured, you may be eligible for compensation for your medical costs, lost income, pain and suffering and other losses. you should speak with an experienced defective medical device attorney as soon as possible.