ANTHEM 71422834Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556531310), received between Dec 31, 2020 and Dec 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.

• MalfunctionDec 8, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, DURING A RIGHT TKA SURGERY WITH ANTHEM, THE BOX OF AN ANTHEM FEMORAL PS COCR SZ 4 RIGHT (PN 71422834, LN 21JM11188) CONTAINED A LEGION PS NP FEM SZ 3 LEFT (PN 71423223, LN 21JM14162) INSTEAD. CEMENT HAD ALREADY BEEN PLACED ON THE PROSTHESIS AT THE TIME OF THE FINDING. A BACK-UP PRODUCT WAS USED TO RESUME THE SURGERY THAT EXTENDED FOR LESS THAN 30 MIN. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15946538 ↗
• MalfunctionDec 31, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING SURGERY WHILE IMPLANTATION, IT WAS FOUND THAT AN ANTHEM FEMORAL PS COCR SZ 4 RT WAS IMPLANTED BUT THERE WERE NO STICKERS IN THE BOX, AS THE STICKERS ARE INSIDE THE BOX, IN THE PROCESS, NURSE OPENED THE BOX, HAND OVER IMPLANTS ONE AFTER ANOTHER, ONCE THE IMPLANTATION WAS DONE THE NURSE GATHER THE STICKERS AND HANDOVER TO US. BUT IN THE FEMORAL BOX THERE WERE NO STICKERS. THE SIZE IMPLANTED IN THE PATIENT WAS THE CORRECT SIZE. NO PATIENT INJURY / IMPACT RESULTED FROM THE REPORTED EVENT, PATIENT WAS DISCHARGED AFTER A SUCCESSFUL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103201 ↗

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