Certain B. Braun Aesculap knee implants have been temporarily suspended from implantation due to a “possible malfunction.” Furthermore, a number of plaintiffs have already filed lawsuits against the manufacturer of the Aesculap knee implant.
No Aesculap Recall, Company Issues Warning
The prosthetics manufacturer notified patients worldwide about the design flaw in a letter on November 16. The company said that a “locally accumulated number of aseptic loosenings have been reported to us in connection with the univation X system. In the affected patients, the loosened knee endoprostheses had to be revised or will be revised.” As of now, there has not been a recall issued on the Aesculap knee.
A loosened knee implant can cause serious problems, such as:
- pain,
- infection,
- problems walking,
- swelling,
- and may require a risky and invasive revision surgery.
This can not only affect your quality of life, but can become rather costly due to missing work for a revision surgery and an increase in medical bills.
B. Braun classified this risk and possible harm to patients as critical and has required surgeons to stop implantations through January 3, 2021, as the company investigates the problem.
B. Braun added in its letter “no technical factor and no connection between the reported cases could be identified” and it will not assume a “product-related malfunction.”
Aesculap Implant System Lawsuit Filed
As reported by the Baltimore Sun, the lawsuit against Bethlehem-based medical device maker B. Braun’s prosthetic joint division alleges the company knew about a problem with its line of ceramic-coated replacement knees, but failed to correct it or warn users.
Aesculap Implant Systems holds a patent in Germany for a solution to the problem but did not incorporate the feature into its products, the lawsuit on behalf of 30 knee replacement patients claims. As a result, glue that is supposed to adhere the implants to patients’ bones does not bond with the replacement knees and causes them to become loose, requiring additional surgeries to correct, the suit alleges.
Numerous surgeons, sales representatives and employees made Aesculap aware that during the follow-up surgeries, the knees could be easily removed without cutting away the bone cement, the suit claims. It alleges that Aesculap intentionally concealed the problem from physicians, salespeople and the U.S. Food and Drug Administration.
Additional Important Information
The Aesculap knee implant system is a ceramic-coated implant advertised as “advanced surface” implants. Sometimes the ceramic coating allows moisture to accumulate under the bone cement. This interferes with the bonding process and can subsequently cause loosening of the device.
The U.S. Food and Drug Administration (FDA) cleared Univation unicondylar knee endoprosthesis systems with a fixed and mobile platform in 2008 and 2013. They are designed to treat medial compartmental knee deformities. According to the company website, the implantation of the femoral and tibial implants take place with bone.
A number of patients have experienced early knee implant failures or malfunctions due to device loosening, and have filed a knee replacement lawsuit against the manufacturer.
Questions About an Aesculap Knee Implant Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review.
If you or someone you love has experienced device loosening or other problems and complications related to the B. Braun Aesculap knee implant, you should contact our lawyers today. You may be entitled to financial compensation by filing an Aesculap knee lawsuit.
We offer a Free Case Evaluation. Please contact us using the form below or by calling us at (800) 279-6386.
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