Aesculap Univation X (knee prosthesis)

2020: Suspension of sales of knee endoprostheses after defects identification

In the middle of November, 2020 B. Notified Braun on suspension of sales of the systems of knee endoprosthesis replacement of Aesculap Univation X after defects identification. The company promises to return a product on the market after eliminates "possible fault".

In the letter of November 16, 2020 sent to clients worldwide the company reported that it received "a number of messages about cases of local aseptic shaking of implants of Univation". At the struck patients the loosened endoprostheses of a knee joint should be replaced or corrected.

Aesculap Univation X is the system of endoprosthesis replacement of a knee joint with the fixed and mobile platform approved by regulatory bodies in 2008 and 2013. It is intended for correction and treatment of deformations of a knee joint with a medial kompartmentation. According to information on the website of the company, femoral and tibial implants are built in a bone.

B. Braun stopped sales of knee endoprostheses after a defects bnaruzheniye

Taking into account the current level of knowledge and the available results of the researches conducted today we did not reveal any technical factors which could lead to defects of products, and did not find communication between the registered cases, said in the letter of the company. - Now we do not assume that the device is faulty, but possible harm to the patient is classified as critically significant.

By estimates of the producer, the share of patients with the loosened endoprostheses makes 0.18% of total number of the operated patients, but company B. Braun just in case recommended to stop use of implants till January 31, 2021, i.e. until the end of investigation. B. Told Braun that is going to carry out all remedial measures on places within 3 months.

The company did not answer questions of journalists of the exact number of injured patients or the mentioned devices.^[1]

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