Evolution EIS7S10LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684EIS7S10L1), received between Dec 3, 2019 and Aug 14, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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)(6).

  Patient problems: Pain

  MAUDE report 19982515 ↗
• InjuryApr 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION REVISION NJR NUMBER: 5064705. SIDE: L . PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. PRODUCTS NOT REVISED: PRODUCT ID: LOT NUMBER: QTY: EFSRN7PL 1929852 1; ETPKN7SL 1923445 1.

  Patient problems: Unspecified Infection

  MAUDE report 16751598 ↗
• InjuryMar 4, 2021Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  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 11413282 ↗
• InjuryMar 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO KNEE TIGHTNESS AND INABILITY TO PERFORM FLEXION. SOFT TISSUES REMOVED AND LINER EXCHANGED WITH THE SAME SIZE LINER. PRODUCT NO REVISED: ADVANCE EVOLUTION PRODUCT ID: K0001288 , LOT # 1746398, QTY 2. EVOLUTION FEMORAL PRODUCT ID: EFSRN7PL, LOT # 1776909. EVOLUTION TIBIAL PRODUCT ID: ETPKN7SL, LOT # 1766941.

  Patient problems: Loss of Range of Motion; Osteopenia/ Osteoporosis; Tissue Breakdown

  MAUDE report 9836007 ↗
• InjuryJan 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 9639452 ↗
• 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 9405369 ↗