ANTHEM 71422694Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556531396), received between Aug 21, 2019 and Jul 3, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryJul 3, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING TKR SURGERY TIBIA DID NOT FIT WELL WITH THE INSERT. FAILED TO FIT WITH INSERT 71422668, #18JB00532. TRIED ANOTHER SIZE INSERT 71422669, #19DM13604. IT WAS ALSO NOT FITTED WELL BUT FORCED TO FIT AND FINISHED THE PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10230714 ↗
• InjuryAug 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PERCUTANEOUS INFERIOR VENA CAVA RETRIEVABLE FILTER IMPLANTATION WAS PERFORMED UNDER LOCAL ANESTHESIA DUE TO DEEP VENOUS THROMBOSIS.

  Patient problems: Injury

  MAUDE report 8919244 ↗

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