Evolution EIS5S10RRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI M684EIS5S10R1), received between May 29, 2019 and Nov 6, 2025 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2025. REVISED ON (B)(6) 2025 DUE TO SUSPECTED INFECTION. CRP LEVEL POST-OP WAS HIGH, INDICATING POTENTIAL INFECTION. CRP LEVELS DROPPED AFTER WASHOUT & INSERT CHANGE. PATIENT CONFIRMED AS HIGH RISK DUE TO MORBID OBESITY AND OTHER MEDICAL HISTORY. AUSTRALIA-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 23486932 ↗
• InjuryJul 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT REVISED DUE TO INFECTION. REVISION NJRINDEXNO: 5504034 SIDE: R NON-REVISED PRODUCTS: PRODUCT ID: ETPKN5SR EVOLUTION® MP TIBIAL BASE KEELED NON-POROUS SIZE 5 STANDARD RIGHT/ LOT NUMBER: 1969944/ QTY: 1. PRODUCT ID: EFSRN5PR EVOLUTION® MP FEM CS/CR NON-POROUS SIZE 5 PRIMARY RIGHT/ LOT NUMBER: 1985234/ QTY: 1.

  Patient problems: Unspecified Infection

  MAUDE report 19778409 ↗
• InjuryNov 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, SUBCLINICAL NERVE DAMAGE AS POSSIBLE RESULT OF SURGICAL TRAUMA RESULTING IN PAIN OR NUMBNESS OF THE AFFECTED LIMB.

  Patient problems: Pain

  MAUDE report 18208412 ↗
• InjuryOct 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT TKR REVISION OF EVOLUTION KNEE DUE TO INFECTION. PRIMARY CASE DETAILS ARE UNKNOWN. WASHOUT WAS PERFORMED, EIS510R INSERT WAS REPLACED WITH ANOTHER OF THE SAME SIZE. AUSTRALIA-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18007425 ↗
• InjuryOct 25, 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 15668401 ↗
• InjuryMay 11, 2022Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO STIFFNESS, COMPONENT NOT REVISED: PRODUCT: ADVANCE ONLAY ALL POLY PATELLA 35MM TRIPEG PRODUCTID: KPONTP35 LOT#:1804141 QTY:1, REVISION NJR NUMBER: (B)(4), SIDE: R , PRIMARY ASA: P1 - FIT AND HEALTHY.

  Patient problems: Loss of Range of Motion

  MAUDE report 14361123 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2015. REVISED ON (B)(6) 2021 DUE TO PAIN. SURGEON RESURFACED THE PATELLA AND REVISED LINER FROM 10MM TO 14MM. (B)(6).

  Patient problems: Pain

  MAUDE report 12360206 ↗
• InjuryDec 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT RIGHT TKR ON (B)(6) 2020, REVISED ON (B)(6) 2020, DUE TO INFECTION. UNDERWENT WASHOUT AND LINER EXCHANGE ONLY. (B)(6); C1000.

  Patient problems: Unspecified Infection

  MAUDE report 10937215 ↗
• InjuryMar 31, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT REVISION SURGERY DUE TO INSTABILITY, THE 10MM LINER WAS REMOVED AND REPLACED WITH A 14MM LINER. DETAILS OF PRIMARY SURGERY ARE NOT KNOWN.

  Patient problems: No Information

  MAUDE report 9904339 ↗
• InjuryJan 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2019, REVISED ON (B)(6) 2019 DUE TO INFECTION. UNDERWENT POLY LINER REMOVAL, WASH OUT AND REPLACEMENT. THE SAME SIZE INSERT WAS USED IN REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 9574653 ↗
• InjuryMay 29, 2019Unstable; Unstable

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO FLEXION INSTABILITY. PATELLA RESURFACING.

  Patient problems: No Information

  MAUDE report 8651788 ↗