ANTHEM 71422695Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556531402), received between Mar 24, 2020 and Dec 26, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

1 other recall cover devices cleared under the same FDA submission (K142807, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2022Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material; Delivered as Unsterile Product; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE INSIDE PACKAGING OF THE ANTHEM TIBIAL BASE PLATE SZ 5 LT WAS MELTED. THE STERILE BOX WAS NOT COMING OUT OF THE PACKAGING AND ALSO STERILITY SEEMED TO BE COMPROMISED. FINAL IMPLANT WAS DIRECTLY PICKED FROM BOX USING STERILE FORCEPS. OUTER PACKAGING OF IMPLANT WAS INTACT, AND IMPLANTS WERE STORED AND TRANSPORTED AS PER INSTRUCTIONS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY (5 MINUTES), USING THE SAME DEVICE AS BACKUP IMPLANT WAS NOT AVAILABLE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048732 ↗
• InjuryApr 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT TRANSFUSIONS (PRC) WERE PERFORMED ON (B)(6) AND ON (B)(6) DUE TO ANEMIA.

  Patient problems: Anemia

  MAUDE report 9938487 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TRANSFUSIONS (PC) WERE PERFORMED ON JULY 25TH AND ON AUGUST 8TH DUE TO A WORSENING THROMBOCYTOPENIA.

  Patient problems: Injury

  MAUDE report 9875934 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142807, 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