Attention: We are no longer accepting case evaluations for Aesculap knee replacements.
Who Is Aesculap Implant Systems?
Aesculap is a medical device company that was founded in Tuttlingen, Germany in 1867. Now, the company is a large surgical instrument manufacturer that produces a variety of different medical and surgical devices. Aesculap entered the joint replacement industry in 1972 in Europe but later became one of the largest implant manufacturers in the world as the 6th largest, but has plans to continue expanding. In 2014, B. Braun, a German medical device manufacturer, acquired Aesculap.
What Is Aesculap’s Total Knee Replacement System?
One of Aesculap’s joint replacement systems is a total knee replacement system. The Aesculap knee replacement is a full knee replacement that, while it can come in different types, including fixed, mobile, and more, is designed to replace the entire knee and connect to both the tibia and the femur, the lower and upper leg bones, respectively. Aesculap recommends that anyone in need of a knee replacement speak with their surgeon in order to determine which knee replacement device is the right fit for them.
Why Are Aesculap Knee Replacement Implants Failing?
No official cause for failure has been given, but many surgeons performing revision procedures are concerned about a lack of bonding cement in the faulty implants, which they believe is caused by the ceramic coating on the implant.
The ceramic coating used in Aseculap knee replacement procedures is called Advanced Surface Technology. There is a concern that this surface does not adhere properly to bone cement, which is often used in knee replacement surgeries. This ultimately results in the loosening of the device. In many such cases, revision surgery is required to replace the implant or to properly secure it using a mechanical bond (e.g., bone screws) to ensure adequate fixation and stability in the knee.
Which Aesculap Knee Replacement Implants Have Failed?
Several different Aesculap knee replacements have been affected by de-bonding issues, including:
- VEGA System
- Columbus Knee System
- Advanced Surface Technology
- Columbus AS Revision Knee System
- EnduRo AS Knee Revision System
- Univation X
Why Are There Aesculap Lawsuits?
Like many medical devices, the Aesculap systems were approved in a short period of time based on the FDA’s 510(k) program. This program alleviates the need for extensive clinical trials and allows manufacturers to gain “automatic approval” for their product as long as they are able to show there is something similar already on the market. This program has brought many much-needed products to market quickly and conveniently, but it has also led to the approval of a substantial number of products that later proved dangerous.
In addition to concerns about adequate testing of the Aesculap systems, there is also evidence the implant’s manufacturer, B. Braun, hid problems with its joint replacement devices and promoted the products to surgeons even though they knew there was a risk of failure.
What Aesculap Lawsuits Are There?
Numerous lawsuits against Aesculap and B. Braun were filed regarding the failure of its knee replacement devices. The lawsuits alleged that the manufacturers were aware of the issues with their knee replacement devices and failed to warn surgeons and patients of the problems that could cause premature failure and require revision surgery. As a result, B. Braun has encouraged surgeons to stop implanting Aesculap knee replacement devices due to the risk. It’s currently unknown whether the lawsuits against the company were settled or for how much.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.