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FDA Warnings

Recall Alert: Zimmer Biomet Shoulder Replacement Device

 

Shoulder Replacement Recall Alert

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, has lead the FDA to initiate this Class I recall.

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 a risk of continued injury. To resolve the issue, healthcare practitioners have had to resort to 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 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 market that Zimmer is still working to recover.

This is the second time that the same device has been pulled from 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 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.

The first individual settlement has been reached for one man suffering adverse health effects from Zimmer’s hazardous device. The case, coming out of the US District Court of Colorado, was filed in 2014 and has finally been resolved more than two years after.

The plaintiff had originally received two separate Comprehensive Reverse Shoulder replacement devices to fix a rotator cuff tear in one arm and severe arthritis in the other. After receiving the implants, both devices fractured, causing the plaintiff high levels of pain and a major loss of motor functions in both arms.

The plaintiff claimed that Biomet had kept the device in the market despite being fully aware of the high likelihood of adverse health effects for consumers.

Biomet agreed to a settlement of $350,000 for the plaintiff. This is likely the first of many lawsuits to be filed against Zimmer Biomet’s Comprehensvie Reverse Shoulder device.

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