B. Braun is warning customers to stop implanting certain Aesculap knee replacement systems due to a “possible malfunction.”

On November 16, B. Braun sent a letter to customers worldwide regarding a growing number of knee implants that loosened and needed surgery.

The company said a “locally accumulated number of aseptic loosenings have been reported to us in connection with the Univation X System. ln the affected patients, the loosened knee endoprostheses had to be revised or will be revised.”

Loose knee implants can cause severe pain, problems walking, infection, swelling, and require an invasive and risky revision surgery.

B. Braun added that “no technical factor and no connection between the reported cases could be identified,” and furthermore, the company is “not assuming a product-related malfunction.”

Even so, B. Braun classified the risk to patients as “critical” and is asking surgeons to halt implants through January 31, 2021, while it investigates the problem and tries to fix it.

Aesculap Knee Implant Systems are ceramic-coated implants that were advertised as “advanced surface” implants. Despite these claims, many patients have experienced early failures due to loosening.

In recent years, dozens of people have filed knee replacement lawsuits claiming that their Aesculap knee implants were defective.

According to the lawsuits, the bone cement fails to properly glue the implants to the bones. This can cause the implant to loosen and require a corrective surgery.

Lawyers say the ceramic coating on the implant allows moisture to accumulate on the surface of the implant under the bone cement, which interferes with the bonding process.

Aesculap is also accused of hiding the problem from the FDA and their customers, despite numerous complaints. One surgeon said “the implant components were easily removed by hand, using just two fingers, or after a single mallet strike,” according to lawsuits.

Source: B. Braun halts certain Aesculap knee implants

Posted by Daily Hornet

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