ANTHEM 71422825Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556531280), received between Sep 6, 2018 and Sep 9, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Dent in Material” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2022Dent in Material; Dent in Material

  IT WAS REPORTED THAT AN ANTHEM FEMORAL PS COCR SZ 5 RT N HAD DENTED TRAY. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15394203 ↗
• InjurySep 6, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR A REMOVAL OF THE INSERT AND FEMUR COMPONENT AS THE PATIENT WAS EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 7853320 ↗

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