Evolution EFSRN6PLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684EFSRN6PL1), received between Jun 24, 2021 and Jun 25, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(4). SIDE: L. GENDER: M.

  Patient problems: Unspecified Infection

  MAUDE report 19610922 ↗
• InjuryMar 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT L TKR ON (B)(6) 2018. REVISED ON (B)(6) 2024 DUE TO INFECTION. ALL COMPONENTS REVISED WITH THE EVOLUTION REVISION SYSTEM. (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 18841791 ↗
• InjuryNov 7, 2022Unexpected Therapeutic Results

  ALLEGEDLY, REPORTER BECAME AWARE OF SOME NITRX COMPLAINTS FROM A SURGEON IN (B)(6) 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 AND (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 TH

  Patient problems: Fluid Discharge; Inflammation; Pain

  MAUDE report 15743522 ↗
• InjuryJul 28, 2021Break; Break

  ALLEGEDLY, THE PATIENT HAS BEEN SUFFERING FROM RESTRICTED MOBILITY AND A FEELING OF TENSION IN THE AREA OF THE LEFT KNEE JOINT FOR ABOUT A YEAR. IN THE PREVIOUS YEAR, SEVERAL PUNCTURES WERE CARRIED OUT WITHOUT EVIDENCE OF THE PATHOGEN. IN JUNE, AN X-RAY EXAMINATION SHOWED A FEMORAL COMPONENT FRACTURE, WHICH IS WHY THE INDICATION FOR A COMPONENT CHANGE WAS MADE. (B)(4).

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

  MAUDE report 12239880 ↗
• InjuryJun 24, 2021Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO LAXATION AND INSTABILITY. (B)(6) (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12060672 ↗