Evolution EIS5P10RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684EIS5P10R1), received between Dec 29, 2020 and Nov 21, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2023. REVISED ON (B)(6) 2023 DUE TO INFECTION. WASHOUT PERFORMED AND INSERT REPLACED WITH ANOTHER OF THE SAME SIZE. AUSTRALIA-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18182297 ↗
• InjuryApr 6, 2022Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. NO REVISED: PRODUCT ID: EFSRN6PR, EVOLUTION MP FEM CS/CR NON-POR PRIMARY SZ 6 RIGHT, LOT: 1845073, QTY: 1. PRODUCT ID: ETPKN5SR, EVOLUTION MP TIBIAL KEELED NONPOR SIZE 5 STANDARD RIGHT, LOT: 1821271, QTY: 1. PRODUCT ID: KPONTP32, ADVANCE ONLAY ALL POLY PATELLA 32MM TRIPEG, LOT: 1880365, QTY: 1. REVISION NJR NUMBER: (B)(4), SIDE: R , PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Insufficient Information

  MAUDE report 14029070 ↗
• InjuryDec 29, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT BILATERAL TKR ON (B)(6) 2020. RIGHT KNEE REVISED ON (B)(6) 2020 DUE TO INSTABILITY. TIBIAL INSERT CHANGED FROM 10MM TO 17MM THICKNESS. (B)(6).

  Patient problems: No Information

  MAUDE report 11089923 ↗