Zimmer Biomet Orthopedic Implants

2020: Withdrawal of defective orthopedic implants due to increased endotoxin content

In mid-July 2020, it became known that Zimmer Biomet recalls polyethylene orthopedic implants sold in Europe due to increased endotoxin content. The volume of recalled products is unknown.

The recall document was signed on April 30, 2020, but appeared in the public domain only on July 16, 2020. According to Zimmer Biomet notification, the problem was detected during routine testing of polyethylene implants. Endotoxins (pyrogens) are substances produced or formed during the life of some bacteria and cause a response of the human body. According to the standards, the level of endotoxin contamination should not be more than 20 EE per device (EE in this case is the unit of measurement of endotoxin activity). During the test, it was found that the bacterial endotoxin content of three samples of polyethylene implants stored for 6 weeks exceeded the standard value adopted by the regulators.

Zimmer Biomet recalls defective orthopedic implants due to bacterial endotoxin contamination

As a result, Zimmer Biomet recalls a number of polyethylene implants to replace knee and hip joints that were manufactured between December 2016 and January 2017. Possible long-term health effects include an adverse local tissue response, a pronounced pain syndrome, and even a serious systemic response to an allergen or toxin. However, patients with implants do not require additional postoperative follow-up.

Defective products were distributed on the market from December 2016 to February 2020. The company said it did not receive complaints related to potentially vulnerable devices. Zimmer Biomet did not respond to a media request for additional information.^[1]

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