Evolution EIS4S12LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684EIS4S12L1), received between Dec 16, 2019 and Oct 26, 2023 — classified as 4 injuries, 1 malfunction.

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

• InjuryOct 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2016 AND L TKR, DATE UNKNOWN, WITH BOTH PATELLAE PRESERVED. BOTH KNEES WERE REVISED ON (B)(6) 2023 DUE TO PATELLA PAIN. PATELLAE ADDED AND INSERTS WERE REPLACED EVEN THOUGH THE IN-SITU ONES WERE IN PRISTINE CONDITION. LEFT KNEE. SURGICAL SPECIALTIES REF (B)(4).

  Patient problems: Pain

  MAUDE report 18013499 ↗
• InjuryOct 18, 2022Malposition of Device; Malposition of Device

  ALLEGEDLY, PATIENT WAS REVISED DUE TO MALALIGNMENT REVISION NJR NUMBER: (B)(4). SIDE: L. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE. PRODUCT NO REVISED: PRODUCT ID: EFSRN3PL, LOT: 1785763, QTY: 1.

  Patient problems: Failure of Implant

  MAUDE report 15625963 ↗
• InjurySep 16, 2021Unstable; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Unstable; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ALLEGEDLY, COMPONENT EXCHANGED DUE TO LIGAMENT LOOSENING. THE COMPONENT EIS4S12L , LOT 1842498 WAS REVISED. REPLACEMENT OF INSERTS. (B)(4).

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

  MAUDE report 12482813 ↗
• MalfunctionFeb 24, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED ON (B)(6) 2019 DUE TO INSTABILITY. SZ 4 12MM REPLACED WITH SZ 4 17MM INSERT. SURGEON ERROR RESULTING IN INSTABILITY. AUSTRALIA C842.

  Patient problems: No Information

  MAUDE report 9747012 ↗
• InjuryDec 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY , PATIENT WAS REVISED DUE TO INFECTION. WASHOUT AND POLY EXCHANGE. (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 9473420 ↗