Evolution EIS6S10RRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI M684EIS6S10R1), received between Dec 16, 2019 and Sep 2, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2025Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2023. REVISED ON (B)(6) 2025 DUE TO INSTABILITY. 10MM INSERT REPLACED WITH A 14MM INSERT. (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 22935254 ↗
• InjuryJul 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: R. NON-REVISED PRODUCTS: PRODUCT ID: EFSRN6PR EVOLUTION® MP FEM CS/CR NON-POROUS SIZE 6 PRIMARY RIGHT/ LOT NO.: 2007053/ QTY: 1. PRODUCT ID: ETPKN6SR EVOLUTION® MP TIBIAL BASE KEELED NON-POROUS SIZE 6 STANDARD RIGHT/ LOT NO.: 2030828/ QTY: 1. PRODUCT ID: KPONTP35 ADVANCE® ONLAY ALL-POLY PATELLA 35MM TRI-PEG/ LOT NO.: 20284692032763/ QTY: 1.

  Patient problems: Unspecified Infection

  MAUDE report 22681604 ↗
• InjuryJun 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: R GENDER: M NON REVISED PRODUCTS: PRODUCT ID: EFSRN6PR EVOLUTION® MP FEM CS/CR NON-POROUS SIZE 6 PRIMARY RIGHT/ LOT NO: 1984097/ QTY: (B)(4). PRODUCT ID: ETPKN6PR EVOLUTION® MP TIBIAL BASE KEELED NON-POROUS SIZE 6 PLUS RIGHT/ LOT NO.: 1989138/ QTY: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 22178252 ↗
• InjuryDec 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Unspecified Infection

  MAUDE report 21021508 ↗
• InjuryJun 26, 2024Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA/INFECTION/LYSIS TIBIA. SRNJR NUMBER: (B)(4). SIDE: R. GENDER: F.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 19620527 ↗
• InjuryMar 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: 5373470, SIDE: R, GENDER: M.

  Patient problems: Unspecified Infection

  MAUDE report 18961600 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, REPORTER BECAME AWARE OF SOME NITRX COMPLAINTS FROM A SURGEON IN IDAHO HOWEVER, NO INFORMATION ABOUT THE COMPLAINTS WERE GIVEN TO REPORTER. MICROPORT ORTHOPEDICS VP R&D PROD. DEVELOPMENT STATED THAT HE RECEIVED A PHONE CALL FROM MIKE SHATZER(SALES REP) SAYING THAT A DOC IN IDAHO HAD A FEW PATIENTS COME BACK IN WITH PAINFUL, SWOLLEN KNEES. HE CONTACTED THE REP TO SEE IF HE COULD GET MORE DETAILS. HE ASKED A SERIES OF QUESTIONS THAT HE DID NOT KNOW THE ANSWER. NO PART/LOT NUMBERS ARE GIVEN AND IT HAS NOT BEEN INDICATED HOW MANY EVENTS/PATIENTS HAVE OCCURRED REGARDING THESE ISSUES. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: A TOTAL OF 8 COMPLAINTS WERE RECEIVED WITH ALL RELEVANT INFORMATION INCLUDED IN EACH INCIDENT FORM. THE 7 REMAINING COMPLAINTS ARE CAPTURED UNDER DIFFERENT MICROPORT INCIDENT GROUP NUMBERS. ALLEGEDLY, RECURRING KNEE EFFUSION. NO INFECTION TO DATE. IT WAS CONFIRMED THAT EACH OF THESE PATIENTS WERE SEEN FOR FOLLOW-UP APPOINTMENTS TO ADDRESS INFLAMMATION IN THEIR KNEES. THE SURGEON CONFIRMED THAT NONE OF THE PATIENTS HAD INFECTIONS AND THAT THEIR KNEES HAD FLUID BUILDUP THAT WAS DRAINED. THE SURGEON HAS NOT BEEN ABLE TO DETERMINE IF THESE EVENTS WERE C

  Patient problems: Fluid Discharge; Inflammation; Pain

  MAUDE report 15711988 ↗
• InjuryMar 8, 2022Appropriate Device Problem Term/Code Not Available

  PATIENT UNDERWENT FULL RIGHT SIDE TKR ON (B)(6) 2021, REVISED ON (B)(6) 2022 WHERE THE LINER WAS REMOVED AND REPLACED WITH A NEW ONE OF THE SAME SIZE, THE REASON WAS WASHOUT DUE TO INFECTION. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 13693870 ↗
• InjuryJun 15, 2021Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT'S RIGHT KNEE INSERT REPLACED DURING A WASH OUT PROCEDURE DUE TO INFECTION. PRIMARY CASE DETAILS UNKNOWN, REVISED ON (B)(6) 2021. (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 11997085 ↗
• InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT UNDERWENT RIGHT TKR ON (B)(6) 2017. REVISED ON (B)(6) 2021 DUE TO INFECTION. 10MM INSERT REPLACED WITH THE SAME SIZE. (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 11565564 ↗
• InjuryJun 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. COMPONENT NOT REVISED: EVOLUTION MP FEM CS/CR NON-POR PRIMARY SZ 6 RIGHT PRODUCT ID: EFSRN6PR LOT #: 1634509. EVOLUTION MP TIBIAL KEELED NONPOR SIZE 6 STANDARD RIGHT PRODUCT ID: ETPKN6SR LOT #: 1621814. REVISION NJR NUMBER: 2928216. SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Unspecified Infection

  MAUDE report 10196587 ↗
• InjuryFeb 26, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT RIGHT TKR ON (B)(6) 2018, PATIENT PRESENTED WITH SLIGHT RECURVATUM DEFORMITY AND INSTABILITY. REVISED ON (B)(6) 2020 WHERE THE 10MM POLY WAS REPLACED WITH A 14MM POLY LINER. (B)(6).

  Patient problems: Loss of Range of Motion

  MAUDE report 9757031 ↗
• InjuryJan 10, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2018, REVISED ON (B)(6) 2019 DUE TO INSTABILITY, 10MM TIBIAL INSERT INCREASED TO 17MM. WHILE REVISING THE SURGEON DECIDED TO REDUCE THE PATELLA FROM 35MM TO 32MM. (B)(6).

  Patient problems: No Information

  MAUDE report 9577959 ↗
• InjuryDec 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT ON (B)(6) 2017. RIGHT SIDE POLY INSERT EXPLANTED, WASH OUT AND REPLACED ON (B)(6) 2019 DUE TO INFECTION. (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 9472749 ↗