Evolution EIS5P14LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684EIS5P14L1), received between Mar 16, 2021 and Mar 16, 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.

• InjuryMar 16, 2021Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT BILATERAL TKR ON (B)(6) 2020. LEFT KNEE REVISED ON (B)(6) 2021 DUE TO PATIENT'S COMPLAINTS OF INSTABILITY. SURGEON BELIEVES REVISION WAS UNNECESSARY BUT PATIENT INSISTED. INSERT CHANGED FROM 14MM THICKNESS TO 17MM. PREVIOUSLY PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY IN (B)(6) 2020, INCIDENT (B)(4). (B)(6)- (B)(4).

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 11496316 ↗