ANTHEM 71422693Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556531389), received between Jan 7, 2020 and Aug 14, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Implant subsidence” (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.

• InjuryAug 14, 2025Loss of Osseointegration; Implant subsidence; Loss of Osseointegration; Implant subsidence

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED IMPLANT SUBSIDENCE AND LOOSENING IN THE TIBIA DUE TO BONE LOSS. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH OXINIUM IMPLANTS WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT REMAINS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22804753 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY (B)(6). SUBJECT: (B)(6). AE#02: IT WAS REPORTED THAT PATIENT UNDERWENT KNEE MANIPULATION TO RESOLVE A ROM LIMITATION ISSUE.

  Patient problems: Injury

  MAUDE report 9557537 ↗

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