EVOLUTION® ETH405L0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684ETH405L01), received between May 7, 2024 and May 7, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, A DOCUMENT WAS EXTRACTED BY THE PMS TEAM INVOLVING DOCTOR (B)(6) (2021) FROM US, 100 PATIENTS IMPLANTED, 1 REVISION (INSTABILITY) AND 18 OTHER COMPLICATIONS THIS INCIDENT IS CAPTURING ONE OF THE 18 COMPLICATIONS, POSITIVE INFECTION IN RIGHT TKA 11 MONTHS POST-OPERATIVE. PER THE PROVIDED REPORT, THIS CASE WAS CONSIDERED BY THE AUTHORS TO BE NON-DEVICE RELATED.

  Patient problems: Unspecified Infection

  MAUDE report 19261546 ↗