Evolution ETPKN7SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684ETPKN7SL1), received between Dec 3, 2019 and Jan 22, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: L. GENDER: M.

  Patient problems: Unspecified Infection

  MAUDE report 21209306 ↗
• InjuryAug 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT L TKR ON (B)(6) 2021 WITH NATURAL PATELLA PRESERVED. PATELLA RESURFACED DUE TO PAIN ON (B)(6) 2024. NO COMPONENTS WERE REVISED. (B)(4).

  Patient problems: Pain

  MAUDE report 19986443 ↗
• InjuryNov 7, 2022Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 7. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. PRODUCTS NO REVISED: PRODUCT ID: EFSRN7PL, LOT: 1827636, QTY: 1. PRODUCT ID: EIS7S12L, LOT: 1786535, QTY: 1. PRODUCT ID: KPONTP38, LOT: 1823561, QTY: 1.

  Patient problems: Unspecified Infection

  MAUDE report 15743933 ↗
• InjuryMar 4, 2021Loss of Osseointegration; Device Dislodged or Dislocated; Migration; Loss of Osseointegration; Device Dislodged or Dislocated; Migration

  ALLEGEDLY, PATIENT UNDERWENT BILATERAL TKR ON (B)(6) 2015. PATIENT PRESENTED WITH PAIN IN LEFT KNEE, SUBSIDENCE TO TIBIA, HEATED BONE SCAN. LEFT KNEE REVISED ON (B)(6) 2021. ON OPENING SURGEON DESCRIBED INSERT AS NOT SEATED PROPERLY. FEMORAL COMPONENT EASILY REMOVED BY HAND WITH CEMENT ATTACHED, TIBIAL COMPONENT EASILY WEDGED UP WITH OSTEOTOMY. INFECTION WAS RULED OUT, LOOSENING WAS DETERMINED AS CAUSE. REPLACED WITH EVOLUTION REVISION SYSTEM WITH EXTENDED CEMENTLESS STEMS. (B)(6).

  Patient problems: Pain

  MAUDE report 11412937 ↗
• InjuryDec 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY , THE PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT ON (B)(6) 2014 AT (B)(6). ON (B)(6) 2014, THE PATIENTS C-REACTIVE PROTEIN (CPR) LEVEL WAS RECORDED AS HIGH AS 234MG/L. ON (B)(6) 2018, THE PATIENTS CPR LEVEL WAS RECORDED AS 284MG/L. SURGEON ADVISED THAT THE PATIENT WOULD REQUIRE 2 SURGERIES, OR LIFE-LONG ANTIBIOTICS IN ORDER TO TREAT THE CONDITION. (B)(6).

  Patient problems: Inflammation; Unspecified Infection

  MAUDE report 9406038 ↗