Evolution EIS8S17LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684EIS8S17L1), received between Jul 15, 2024 and Jul 15, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (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. How this data works · Data updated Oct 13, 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.

• InjuryJul 15, 2024Unstable; Unstable

  ALLEGEDLY, PATIENT HAD A SECOND L TKR REVISION DUE TO INSTABILITY. PRIMARY CASE FROM (B)(6) 2018, REVISED ON (B)(6) 2019 DUE TO INSTABILITY. 10MM INSERT REPLACED WITH 17MM (MPO REF 19030012, SSP REF C750). PATIENT REVISED AGAIN ON (B)(6) 2024 DUE TO INSTABILITY, THE 17MM INSERT REPLACED WITH A 20MM INSERT. ALL THREE CASES WERE PERFORMED BY (B)(6). NON REVISED PRODUCTS: PRODUCT ID: KPONTP35 ADVANCE® ONLAY ALL-POLY PATELLA 35MM TRI-PEG/ LOT NUMBER: 1764903/ QTY: 1. PRODUCT ID: EFSRN8PL EVOLUTION®MP FEM CS/CR NON-POR SIZE 8 PRIMARY LEFT/ LOT NUMBER: 1637019/ QTY: 1. PRODUCT ID: ETPKN8SL EVOLUTION®MP TIB KEELED NONPOR SIZE 8 STANDARD LEFT/ LOT NUMBER: 1586733/ QTY: 1. (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19742854 ↗