B. Braun is notifying customers who purchased certain Aesculap knee systems to temporarily cease implanting them while the company addresses a “possible malfunction.”
In a Nov. 16 letter sent to customers worldwide, the company said a “locally accumulated number of aseptic loosenings have been reported to us in connection with the univation X system. ln the affected patients, the loosened knee endoprostheses had to be revised or will be revised.”
With versions FDA-cleared in 2008 and 2013, Univation is a unicondylar knee endoprosthesis system with a fixed and mobile platform, designed to treat medial compartmental knee deformities. The implantation of the femoral and tibial implants takes place with bone, according to the company website.
“According to the current state of knowledge and the results of the investigations carried out to date, no technical factor and no connection between the reported cases could be identified,” the letter added. “We are currently not assuming a product-related malfunction. The possible harm to the patient is classified as critical.”
The company estimates a rate of 0.18% affected products but advised halting implants through Jan. 31, 2021 while it investigates. B. Braun said it plans to complete the field corrective action within 3 months.
The company did not immediately respond to questions about the number of patients or devices affected.
