About B. Braun Aesculap Knee Implants

Braun Aesculap initially developed its ceramic-coated knee implants in an effort to eliminate the toxic shedding of metal debris within the body associated with bare metal implants and marketed its “advanced surface” products as superior and longer-lasting than standard knee devices. However, reports indicate that the ceramic coating on Aesculap’s implants may allow moisture to accumulate on the surface of the implant beneath the surgical glue, which is meant to adhere the device to the patient’s leg bones. As a result, the knee implants can become loose, causing persistent pain, joint instability and difficulty walking. Lawsuits brought against Aesculap allege that the company knew that applying an additional coating to the implants would improve their bond, yet never incorporated the solution into its products.

Like many newer knee replacement systems, the B. Braun Aesculap knee implants were fast-tracked via the FDA’s 510(k) premarket program, which expedites the approval of certain medical devices. Under the 510(k) program, medical device makers can bring their products to market without rigorous testing, so long as the products are “substantially equivalent” to devices already on the market. While this fast-tracked approval process is beneficial in that it gives consumers expedited access to potentially life-altering medical devices, it can also result in new medical devices being automatically approved based on the merits of potentially defective devices that are eventually recalled from the market. When Aesculap submitted its knee replacement system to the FDA for premarket approval, the company claimed that the ceramic-coated implants were similar to products already on the market, thereby bypassing the agency’s more rigorous medical device approval process.

Surgeons performing revision surgery on patients with Aesculap knee implants have reported being able to easily remove the implant components by hand, which suggests an inadequate bond between the implant and the bone cement typically used in knee replacement surgeries. In cases where a knee implant fails to bond properly to the patient’s bones, revision surgery may be required to replace the implant or to insert bone screws or another type of mechanical bond to ensure adequate fixation and stability in the knee joint. Unfortunately, rather than acknowledging the problem with its artificial knees and implementing a solution to fix the bonding failures moving forward, Aesculap has instead blamed the adherence issue on surgeons’ cementing techniques and the use of certain bone cement brands.