Evolution EIS5S12RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684EIS5S12R1), received between Jun 27, 2019 and Oct 9, 2023 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 9, 2023Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT BILATERAL TKR ON (B)(6) 2020, REVISED ON (B)(6) 2023. PATIENT PRESENTED WITH INSTABILITY ON THE LATERAL SIDE AND SURGEON ALSO FELT THAT REPLACING THE PATELLA MIGHT ELIMINATE THE ANTERIOR KNEE PAIN THEY WERE EXPERIENCING. PATELLA ADDED AND 12MM INSERT REPLACED WITH A 14MM ONE. AUSTRALIA: (B)(4).

  Patient problems: Pain

  MAUDE report 17894119 ↗
• InjuryJun 16, 2021Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2021, REVISED ON (B)(6) 2021 DUE TO INFECTION. INSERT REPLACED FOR ONE OF THE SAME SIZE. (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 12013701 ↗
• InjuryOct 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9225838 ↗
• InjuryJun 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT UNDERWENT RIGHT TKR ON (B)(6) 2016. POLY LINER REVISED FROM 10MM TO 12MM THICKNESS ON (B)(6) 2018, REASON UNKNOWN. (LINKED TO 19060176).

  Patient problems: No Information

  MAUDE report 8740853 ↗