Zimmer Biomet, an Indiana-based medical device company specializing in shoulder replacement implant devices, has recently had to recall more than 3,000 of their artificial shoulder replacement implants. Increased rates of medical device reports, suggesting that the implants have a high likelihood of post-op fracturing, lead the FDA to initiate this Class I recall. A Class I recall is the most serious recall issued by the FDA indicating a serious risk of serious injuries or even death.
The Biomet Comprehensive Reverse Shoulder replacement device will fracture inside the patient’s shoulder, leaving the patient with little-to-no shoulder motor function and risk of continued injury. To resolve the issue, healthcare practitioners have had to resort to a post-operational surgical correction, an invasive process that can lead to potential harms including “permanent loss of shoulder function, infection, or rarely, death” as explained by an FDA report.
According to reports from Zimmer’s recall, the issue seems to stem from a malfunction in the Comprehensive Reverse Shoulder device’s “humeral tray”, a composing piece that has a tendency to break away from the device. According to Zimmer, their product does carry a consumer warning label. However, the company has stated, “the devices are fracturing at a higher rate than is stated in the labeling.”
The company first issued the recall in December 2016, urging healthcare institutions to “quarantine” all remaining Comprehensive Reverse Shoulder replacement devices. There are nearly 3,660 devices still on the market that Zimmer is still working to recover.
This is the second time that the same device has been pulled from the market. The first recall occurred in 2010 when Biomet, which has since been bought out by Zimmer, was forced to pull their Comprehensive Reverse Shoulder replacement device from the market due to the high reports of post-op fracturing. Just like the current product, it was the device’s humeral tray that had a tendency to break away from the device after surgery.
Neither Zimmer nor the FDA has issued statements on how they plan to address serving the patients who have already received the recalled devices.