More than half a million people undergo knee replacement operations every year. In many cases, these replacement devices provide more mobility and relief from pain.
Unfortunately, many knee replacement recipients experience complications and are forced to undergo risky revision procedures because their devices fail. Though this is often due to malfunctioning parts on the device, in the case of Aesculap Knee Replacements, the problems are related to the device’s ability to bond to the patient’s natural bone.
Are Aesculap Knee Replacement Devices Safe?
Patients who have undergone knee replacement surgery and received Aesculap knee replacement devices are reporting painful side effects. Many have been forced to undergo follow-up procedures to repair or remove their devices.
The FDA has received reports about an increasing number of incidents since the beginning of 2016 regarding the need for revision surgery for recipients of Aesculap Knee Replacement systems.
Patients are reporting problems with the loosening of their devices.
In many instances, surgeons performing the revision procedures have noted a complete absence of the bonding cement in follow-up surgeries. One surgeon performed 16 revision surgeries on devices that were no more than four years old and found all of the devices had been affected by cement debonding.
In many cases, revision surgeries require surgeons to use a saw to remove the device because the adhesion between the bone and the replacement device is so strong.
Surgeons have reported being able to remove Aesculap components without any assistance, simply pulling components from the patient’s body by hand because there was no bond between the device and the bone.
Implant Failure Rates High with Aesculap Knee Replacements
Cement debonding issues are causing early implant failure of Aesculap Knee Replacement devices.
Though there has been no official reason given for what is causing the debonding issues, some believe the problem is with the coating or design of the Aesculap knee replacement. It might be preventing the cement from adhering to the device.
There is also speculation that the debonding incident rate might appear much lower than it actually is because it can be difficult to identify issues on an x-ray.
Knee replacement implant failure causes a variety of negative side effects, including:
• Intense pain
• Decreased range of motion
• Joint instability
• Need for risky and invasive revision surgery
• Long-term rehabilitation
• Permanent bone loss and muscle damage
• Infection and swelling
• Need to take time away from work
• Expensive medical bills
• Diminished quality of life
The following Aesculap Knee Implant systems could be affected by debonding issues:
• VEGA System
• Columbus Knee System
• Advanced Surface Technology
• univation X
• Columbus AS Revision Knee System
• EnduRo AS Knee Revision System
Is there a Recall for Aesculap Knee Replacement Systems?
As of early spring 2018, there has been no official recall issued for Aesculap Knee Replacement devices.
The manufacturer of these devices, B. Braun, has been accused of concealing from regulators that the problem with debonding could be linked to the ceramic coating on its devices. The company is also accused of continuing to promote the Aesculap Knee Replacements to surgeons despite knowing there was a high risk of failure.
According to one lawsuit that includes 25 Aesculap recipients filed in California, B. Braun marketed its “advanced surface” knees as superior to other options, all the while knowing there could be a problem. The company told surgeons the devices would last longer but knew the cement used in the procedures would not bond properly its devices.
All of the knee replacement patients involved in the lawsuit must undergo revision surgeries to correct the problem – something that seems to be happening at an alarming rate for recipients of Aesculap Knee Replacement recipients.
Further claims include B. Braun failed to properly test its device before sending it to market and ended a clinical trial early when a problem with the cement bonding was noticed.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.