Evolution EFSRN5PLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684EFSRN5PL1), received between Mar 2, 2021 and Oct 21, 2024 — classified as 5 injuries.

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

• InjuryOct 21, 2024Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  ALLEGEDLY, PATIENT IS SCHEDULE FOR REVISION DUE TO LEFT KNEE FEMORAL AND TIBIAL LOOSENING, PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 20500138 ↗
• InjuryJul 15, 2024Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT L TKR ON (B)(6) 2022. REVISED ON (B)(6) 2024 DUE TO PAIN ON STANDING AND INSTABILITY. ALL COMPONENTS REVISED WITH ANOTHER MANUFACTURER'S SYSTEM. DURING REVISION ALL COMPONENTS WERE NOTED TO BE WELL FIXED. (B)(4) AUSTRALIA.

  Patient problems: Pain

  MAUDE report 19742833 ↗
• InjuryJun 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, IN A HOSPITAL IN ASTURIAS, THERE IS A PATIENT WHO UNDERWENT SURGERY A YEAR AGO AND CONTINUES TO REPORT CONTINUOUS PAIN. WHEN EVALUATING POSSIBLE CAUSES, ONE OF THE DOCTORS INDICATES THAT HE BELIEVES THE FEMORAL COMPONENT IS FRACTURED IN ITS PROXIMAL PART. ADDITIONAL INFORMATION RECEIVED ON 05/28/2024: FIRST SURGERY ON (B)(6) 2021 WITHOUT PATELLA AFTER SOME TIME, SHE REFERS ANTERIOR PAIN (SUSPECT PATELLA) AND ON (B)(6) 2023 SHE UNDERGOES A SECOND SURGERY TO IMPLANT THE PATELLA. DOCTOR STATES NOTHING SUSPICIOUS IS OBSERVED. SHE STILL REFERS THE SAME KIND OF PAIN (ANTERIOR), AND AFTER A TC THE RADIOLOGIST STATES IN HIS REPORT (ATTACHED) THAT THERE´S A MORPHOLOGIC ALTERATION OF THE FEMORAL COMPONENT WITH AN EXISTING CAVITY OF IRREGULAR WIDTH AND SHARPENED AROUND THE INTERCONDYLAR REGION THAT'S COMPATIBLE WITH A BREAKAGE IN THE PROSTHESIS. THE SURGEON IS REALLY CONCERNED AS, DESPITE HE DOESN'T BELIEVE THAT THE FEMORAL COMPONENT COULD BREAK, THERE´S A FORMAL REPORT OF THE HOSPITAL STATING THERE´S A PROBLEM AND PROSTHESIS FAILURE. HE IS SUSPICIOUS ABOUT ANY KIND OF BUBBLE OR IRREGULARITY IN THE FEMORAL COMPONENT BUT STILL CANNOT FIGURE OUT IF THIS ISSUE WILL BE THE ROOT-CAUSE O

  Patient problems: Pain

  MAUDE report 19586774 ↗
• InjuryMay 16, 2023Noise, Audible; Noise, Audible

  ALLEGEDLY, PATIENT GOT A KNEE REPLACEMENT ON (B)(6) 2019, AND HAS BEEN EXPERIENCING PAIN ON IT EVER SINCE. PATIENT IS STATING HE NEEDS A REPLACEMENT BUT DOES NOT HAVE A DATE. THE KNEE IS POPPING AND CLICKING AND HAS BEEN SINCE THE INITIAL SURGERY.

  Patient problems: Pain

  MAUDE report 16938759 ↗
• InjuryMar 2, 2021Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT LEFT TKR ON (B)(6) 2018. REVISED ON (B)(6) 2021 DUE TO LIGAMENT LAXITY AND INSTABILITY. REPLACED WITH THE EVOLUTION REVISION SYSTEM WITH STEMS AND AUGMENTS. ADDITIONAL HISTORY - PATELLA RESURFACED ON (B)(6) 2019 AND INSERT REPLACED FROM 10MM TO 14MM, REASON UNKNOWN. (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 11400170 ↗