Evolution EIS4P10RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684EIS4P10R1), received between Mar 11, 2021 and Nov 6, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2023. REVISED ON (B)(6) 2025 DUE TO INFECTION. INSERT REVISED WITH ANOTHER OF THE SAME SIZE. (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 23486955 ↗
• InjuryJul 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2024. REVISED ON (B)(6) 2024 DUE TO INFECTION. WASHOUT PERFORMED AND THE LINER REPLACED WITH ANOTHER OF THE SAME SIZE. AUSTRALIA-C24-288.

  Patient problems: Unspecified Infection

  MAUDE report 19690907 ↗
• InjuryNov 4, 2022Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2019. REVISED ON (B)(6) 2022 DUE TO INSTABILITY. 10MM INSERT REPLACED WITH 17MM INSERT. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15726024 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(6), SIDE: R, PRIMARY ASA: P1 - FIT AND HEALTHY, (B)(6) REFERENCE NO: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11657377 ↗
• InjuryMar 11, 2021Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT RIGHT TKR ON (B)(6) 2017. BASE PLATE SUBSIDED INTO TIBIA RESULTING IN SIGNIFICANT VALGUS AND INSTABILITY. PATIENT REVISED ON (B)(6) 2021 WITH EVOLUTION REVISION TIBIAL BASE AND STEM EXTENSIONS. LINER REPLACED WITH A 20MM ONE.(B)(6)- C1062.

  Patient problems: Failure of Implant

  MAUDE report 11467043 ↗