Evolution EAI4212LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684EAI4212L1), received between Feb 9, 2021 and Feb 9, 2021 — classified as 1 injury.

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

• InjuryFeb 9, 2021Unstable; Unstable

  ALLEGEDLY, THE PATIENT WAS OVEREXTENDING. THE FEMUR AND INSERT WERE REVISED. A REVISION FEMORAL WITH AUGMENTS AND A STEM EXTENSION WERE IMPLANTED ALONG WITH A THICKER INSERT. LEFT KNEE. ADDITIONAL INFORMATION RECEIVED ON 01/19/2021 FROM RELIABILITY ENGINEER: PRODUCT ID'S AND LOT NUMBERS FOR PRODUCTS REVISED, DATE OF ORIGINAL AND REVISION SURGERY. ADDITIONAL INFORMATION RECEIVED ON 01/19/2021 FROM SALES REP (B)(6): EXPLANATION ABOUT WHY THE REVISION SURGERY WAS RESCHEDULED FROM (B)(6) 2021 TO (B)(6) 2021 (CHANGED REQUESTED IMPLANT'S SIZE).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11301122 ↗