Evolution EIS6S12LRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M684EIS6S12L1), received between Jul 18, 2019 and Nov 6, 2025 — classified as 7 injuries.

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 7 most recent of 7 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 SECOND L TKR REVISION DUE TO INFECTION ON (B)(6) 2025. INSERT REPLACED WITH ANOTHER OF THE SAME SIZE. PRIMARY CASE TOOK PLACE ON (B)(6) 2024. FIRST REVISION DUE TO INFECTION TOOK PLACE ON (B)(6) 2025 ((B)(4)). AUSTRALIA (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 23486935 ↗
• InjuryFeb 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, INFECTION. SIDE: L. REVISION NJR: (B)(6). GENDER: F. EXPLANTED: TIBIAL LINER.

  Patient problems: Unspecified Infection

  MAUDE report 18743359 ↗
• InjuryNov 3, 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 (B)(6) (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 10/05/2022: 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 CAUSED

  Patient problems: Inflammation; Pain

  MAUDE report 15722546 ↗
• InjuryAug 3, 2022Therapeutic or Diagnostic Output Failure

  ALLEGEDLY, COMPLETE FEMORAL AND TIBIAL BIPOLAR LOOSENING, MAJOR OSTEOLYSIS OF THE FEMORAL EPIPHYSIS AND METAPHYSIS PRESERVING THE CORTICALS, ABUNDANT FIBRINOUS TISSUE, DIFFUSE DEPOSITS OF INTRA-OSSEOUS AND INTRA-ARTICULAR FIBRIN. LESS OSTEOLYSIS AT THE TIBIAL LEVEL. NO ISSUE WITH THE PATELLA.

  Patient problems: Osteolysis

  MAUDE report 15158915 ↗
• InjuryJun 2, 2020Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION , LINER WAS REPLACE AND SITE WASHED OUT.(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 10112582 ↗
• InjuryJan 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. UNDERWENT WASHOUT AND POLY LINER EXCHANGE ONLY. (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 9553811 ↗
• InjuryJul 18, 2019Unstable; Unstable

  REVISION INSERT CHANGE LEFT TKR-POLY EXCHANGE. PATIENT LOOSE IN EXTENSION-LATERAL COMPARTMENT. PATELLA LIFT OFF-PATELLA IMPLANT REMOVED-FRACTURE OBSERVED POST REMOVAL 12MM LEFT CS INSERT REMOVED, 35MM PATELLA REMOVED. 14MM LEFT CS IMPLANTED. NO PATELLA REPLACED AND NO FIXATION OF PATELLA. KNEE STABLE IN FLEXION AND EXTENSION.

  Patient problems: No Information

  MAUDE report 8804292 ↗