Anthem 71422953Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556655900), received between Jul 28, 2021 and Jul 28, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K170648, K230653); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THREE DAYS AFTER TKA SURGERY HAD BEEN PERFORMED WITH ANTHEM FEMORAL CR COCR SZ 3 RT ON (B)(6) 2019, THE CLINICAL SUBJECT EXPERIENCED A DEEP VEIN THROMBOSIS (DVT) WHICH WAS INITIALLY ASSESSED AS UNRELATED TO EITHER STUDY DEVICE OR STUDY PROCEDURE. THIS ADVERSE EVENT WAS TREATED BY MEDICATION (ELIQUIS) ON (B)(6) 2019. ON 13-07-2021 IT WAS CLARIFIED THAT THE EVENT WAS CAUSED BY THE STUDY PROCEDURE. CURRENT HEALTH STATUS OF THE CLINICAL SUBJECT IS RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12236159 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170648, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint