Evolution EIS3P17RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684EIS3P17R1), received between Dec 11, 2024 and Dec 11, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT HAD A NON-MPO TKR REQUIRING REVISION DUE TO INFECTION. A SPACER WAS PLACED ON (B)(6) 2023, WITH EVOLUTION REVISION KNEE IMPLANTED SECOND STAGE ON (B)(6) 2023. THE PATIENT DEVELOPED A FUNGAL INFECTION, REQUIRING ANOTHER REVISION ON (B)(6) 2024. DUE TO DEBRIDEMENT THAT WAS DONE DUE TO THE INFECTION THE SURGEON DECIDED THAT A THICKER INSERT WOULD BE MORE SUITABLE. REVISED WITH A 20MM INSERT. PRODUCTS IMPLANTED DURING REVISION SURGERY: PRODUCT: ETRKN3SR "EVOLUTION® REV TIB BASE NONPOR", LOT: 1814397, QTY: 1. PRODUCT: ETRKMK36 "EVOLUTION® REV TIB MOD KEEL", LOT: 1984317, QTY: 1. PRODUCT: ESP18100 "EVOLUTION® CANAL FILL STEM EXT", LOT: 1807034, QTY: 1. PRODUCT: EFPAN404, "EVOLUTION® REVISION POSTERIOR" LOT: 1754543, QTY: 1. PRODUCT: ESRF0425, "EVOLUTION® FEM OFFSET ADAPTER", LOT: 1755164, QTY: 1. PRODUCT: ESP17100, "EVOLUTION® CANAL FILL STEM EXT", LOT: 1788874, QTY: 1. PRODUCT: EFSRN4RR "EVOLUTION® FEMORAL STEMMED CS" LOT: 1926304, QTY: 1. AUSTRALIA - C24-560.

  Patient problems: Unspecified Infection

  MAUDE report 20906899 ↗