Anthem 71422933Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556655788), received between Mar 15, 2021 and Jul 28, 2021 — classified as 2 injuries.

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 2 most recent of 2 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, AFTER TKA SURGERY HAD BEEN PERFORMED WITH ANTHEM FEMORAL CR COCR SZ 3 LT ON (B)(6) 2019, 10 DAYS LATER 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 (CUOXANE) ON (B)(6) 2019. ON 13-07-2021 THE SITE HAD CLARIFIED THAT THE EVENT WAS CAUSED BY THE STUDY PROCEDURE, AT WHICH POINT THE EVENT WAS CLASSIFIED AS SERIOUS ADVERSE DEVICE EFFECT (SADE). CURRENT HEALTH STATUS OF THE CLINICAL SUBJECT IS RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12235997 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER BILATERAL TKA THE PATIENT DEVELOPED DEEP VEIN THROMBOSIS ON THE LEFT SIDE. THE EVENT WAS TREATED VIA MEDICATION. THE PATIENT STATUS IS CURRENTLY UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Cardiovascular Dysfunction/Insufficiency; High Blood Pressure/ Hypertension

  MAUDE report 11479269 ↗

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