Second Recall for Zimmer Biomet’s Comprehensive Reverse Shoulder
Prominent medical device manufacturer Zimmer Biomet is issuing a recall of its Comprehensive Reverse Shoulder Device. The company has had to recall several products over the years, and has received thousands of complaints from consumers.
Zimmer Biomet, the company that manufactured faulty Zimmer Knee devices, has issued a recall for its Comprehensive Reverse Shoulder product. The recall comes just as the Food and Drug Administration also released a copy of its 2016 inspection of Zimmer Biomet facilities, which shows that the company received numerous citations for objectionable conditions.
Zimmer Biomet Receives Citations from the FDA
The Food and Drug Administration’s review of Zimmer Biomet facilities lasted from September through November of 2016. The inspection revealed that the company had low standards in some areas of its production, and failed to meet standards in other areas. Some of the issues that the FDA found are that the company:
- Did a poor job of sterilizing products
- Had poor quality control for water used in manufacturing, cleaning, and passivating (coating) medical devices
- Did not have an effective method of detecting faulty or flawed “nonconforming” products
- Had no procedures for fixing problems with nonconforming products
- Had no procedure for proactively identifying problems that may lead to product recalls
These issues are concerning, especially considering that the company has issued multiple product recalls for its devices. Particularly troubling is that, even though between the years of 2014 and 2016 Zimmer Biomet received over 15,000 complaints from consumers about its products, the company still doesn’t have a department dedicated to reviewing and addressing patient concerns.Zimmer Biomet received 14 citations from the FDA.
Class I Recall of Comprehensive Reverse Shoulder
The Comprehensive Reverse Shoulder is a shoulder replacement device that is used to restore mobility in a patient’s arm. The product has been fracturing at a rate that is higher than what was advertised, meaning that the device can break after being implanted. If a fracture occurs, patients will most likely need a revision surgery. Revision surgeries come with the risk of:
- Permanent loss of shoulder function
- Death (in rare cases)
This is not the first time that the Comprehensive Reverse Shoulder device has been recalled. In September of 2010, the Biomet company (which has since merged to become Zimmer Biomet) sent an Urgent Medical Device Recall Notice to its customers and product distributors. The notice suggested that doctors take care to monitor patients for fracturing of the Comprehensive Reverse Shoulder.
While the previous recall of the Comprehensive Reverse Shoulder device was labelled as Class II by the Food and Drug Administration, the current recall is a Class I Recall. Class I is considered the most serious type of medical device recall. It is issued if there is a “reasonable chance that a product will cause serious health problems or death.” Over 3,500 Comprehensive Reverse Shoulders have been recalled from 300 different product lots. In response to the recall, Zimmer Biomet and the FDA are asking that medical professionals review their stock of Comprehensive Reverse Shoulder devices and return any affected products to the manufacturer.
Next Steps for Patients with Faulty Comprehensive Reverse Shoulders
The Comprehensive Reverse Shoulder is not the first Zimmer Biomet product to receive attention for causing consumer problems. Many patients encountered issues with the company’s NexGen knee replacement devices, which have been loosening prematurely after being implanted. Nearly 6,000 knee replacement lawsuits against Zimmer Biomet have been consolidated in a multi-district litigation case (MDL) in Illinois. The initial bellwether trials for the MDL have already been conducted.
There are no additional measurements recommended for patients apart from standard surgical follow up procedures. However, consumers who received a Zimmer Biomet Comprehensive Reverse Shoulder between October 2008 and September 2015 may have had a faulty product implanted. These patients may feel most comfortable scheduling an additional appointment with their doctor to discuss the likelihood of a fracture, and what to do if a fracture occurs.
The first lawsuit regarding the device was filed in Colorado in 2016. The patient in question, Alfonso Alarid, had experienced fractures from two different Comprehensive Reserve Shoulder devices, and was awarded $350,000 for damages and liabilities. Patients who find that their health has been compromised by a Comprehensive Reserve Shoulder may consider taking similar action.