Evolution EIS6S10LRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M684EIS6S10L1), received between Aug 26, 2019 and Jun 26, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2024Insufficient 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 19616343 ↗
• InjuryJun 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: L. GENDER: M. NON REVISED PRODUCTS: PRODUCT ID: EFSRN5PL EVOLUTION® MP FEM CS/CR NON-POROUS SIZE 5 PRIMARY LEFT/ LOT. NO.: 1973342/ QTY: 1. PRODUCT ID: ETPKN6SL EVOLUTION® MP TIBIAL BASE KEELED NON-POROUS SIZE 6 STANDARD LEFT/ LOT. NO.: 197723/ QTY: 1.

  Patient problems: Unspecified Infection

  MAUDE report 19615999 ↗
• InjurySep 6, 2023Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT L TKR ON (B)(6) 2022. REVISED ON (B)(6) 2023 DUE TO INSTABILITY. 10MM INSERT REPLACED WITH A 14MM ONE. AUSTRALIA-(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17692035 ↗
• InjuryJun 20, 2022Output Problem; Loosening of Implant Not Related to Bone-Ingrowth

  ALLEGEDLY, 7 MONTHS POST OP HAD INCREASED WEIGHT BEARING PAIN. 44 MONTHS POST OP- NO COMPLAINT JUST VISIT TO DOCTOR BUT CAN SEE SOME LOOSENING. ON (B)(6) 2022 PATIENT WAS IN PAIN, HYPERFLEX OCCURRED IN SHOW DUE TO OTHER ISSUES COMPONENTS HAVE NOT BEEN REVISED. THIS WAS A PROPHECY CASE: (B)(4).

  Patient problems: Pain

  MAUDE report 14750122 ↗
• InjuryApr 6, 2022Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PX UNDERWENT TKR ON (B)(6) 2016, REVISED ON (B)(6) 2022 DUE TO INFECTION. UNDERWENT WASHOUT AND LINER EXCHANGE ONLY. DOES NOT NEED TO BE REPORTED TO THE TGA AS THE REVISION OCCURRED DUE TO INFECTION (EXEMPTION RULE #8).

  Patient problems: Unspecified Infection

  MAUDE report 14028922 ↗
• InjuryDec 29, 2021Difficult to Insert; Difficult to Insert

  ALLEGEDLY, PATIENT UNDERWENT PRIMARY TKR ON (B)(6) 2021. DURING SURGERY, POLY LINER WOULD NOT LOCK IN AFTER MULTIPLE ATTEMPTS, CAPTURES WERE CLEAR LOOKED GOOD AND STILL WOULD NOT LOCK IN. LINER DISPOSED OF, NEW LINER OPENED AND FIT FINE. SURGERY DELAYED BY 40 MINS. (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13112633 ↗
• MalfunctionOct 22, 2019Unstable; Unstable

  ALLEGEDLY, POLY INSERT REVISED DUE TO INSTABILITY. FROM SZ 6 10MM TO SZ 6 14MM.

  Patient problems: No Information

  MAUDE report 9219233 ↗
• InjuryAug 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE SURGEON REMOVED THE INSERT TO GAIN ACCESS OF THE KNEE SO HE COULD CLEAR OUT TISSUE-KNEE DEBRIDEMENT. SAME SIZE INSERT WAS IMPLANTED AFTER EXCESS TISSUE REMOVAL (EIS6S10L LOT: 1784846).

  Patient problems: No Information

  MAUDE report 8930621 ↗