Braun is notifying customers who bought certain Aesculap knee systems to temporarily halt implanting them while the company addresses a possible malfunction involving these devices. According to a report on Mass Devices, in a Nov. 16 letter sent to customers worldwide, the company reported a “locally accumulated number of aseptic loosenings” in connection with the univation X system.
Possibility for Serious Harm
The company said the affected patients, “the loosened knee endoprostheses had to be revised or will be revised.” Endoprosthesis is an artificial device to replace a missing bodily part that is placed inside the body. Univation is a unicondylar knee endoprosthesis system with a fixed and mobile platform, designed to treat medial compartmental knee deformities. The U.S. Food and Drug Administration (FDA) cleared Versions of the devices in 2008 and 2013.
The company’s website says that implantation of the femoral and tibial implants takes place with bone. Based on what they know now, company officials said their investigations have not shown any technical problems or defects that led to the loosening of the implant. However, the company says that the possible harm to the patient is “critical.” B. Braun has advised halting implants through Jan. 31, 2021 while it investigates the matter further. The company has not said how many patients or devices have been affected because of these malfunctions.
Product Liability Issues
Our California product defect lawyers have represented a number of clients who have been injured or seriously harmed as a result of hip and knee implants as well as other medical devices that malfunction. When it comes to medical devices that are implanted in patients’ bodies, the only way to correct problems is to perform surgery to remove or repair the device.
In such cases, a number of different persons or entities may be held liable for injuries and damages suffered by victims. A manufacturer, supplier or seller of the defective device could also be held liable. A physician, healthcare provider or hospital implanted a faulty device can also be held accountable.
If you or a loved one has been injured by a defective medical device, you may be able to seek compensation for damages such as medical expenses, lost income, cost of surgery, hospitalization and rehabilitation, as well as pain and suffering. An experienced product defect attorney can help you understand your legal rights and options better.