Evolution ETPKN5SLRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M684ETPKN5SL1), received between Feb 16, 2021 and Jul 18, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 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)(6).

  Patient problems: Pain

  MAUDE report 19777077 ↗
• 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 19589346 ↗
• InjuryMar 12, 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. AUSTRALIA-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 18887565 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, A PATIENT IMPLANTED WITH MPO COMPONENTS ON JUNE 21ST HAS EXPERIENCED A RASH ON HER SKIN. THE PATIENT HAS SALMONELLA AND SHE HAS HAD THREE SURGERIES AND CANNOT GET RID OF THE RASH. THEREFORE, THE SURGEON IS REQUESTING FOR THE METAL AND PLASTIC COMPOSITION OF THE COMPONENTS TO DETERMINE IF THE PATIENT IS EXPERIENCING AN ALLERGIC REACTION TO THE IMPLANT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13862079 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WENT TO REVISION DUE TO INFECTION. (B)(6).

  Patient problems: Unspecified Infection

  MAUDE report 11803245 ↗
• 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)(6).

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

  MAUDE report 11400114 ↗
• InjuryFeb 16, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, WHEN THE INSERT WAS REMOVED DURING THE TKA REVISION OPERATION, THERE WERE CLEAR SIGNS OF LIPID ABSORPTION AND PARTICIPATION IN THE REMOVED INSERT, CAUSING DELAMINATION AND PITTING. PHYSICIAN'S FINDINGS: SINCE THIS IS AN EARLY PHENOMENON WITHIN 2 YEARS AFTER SURGERY, THERE ARE CONCERNS ABOUT PRODUCT PROBLEMS AND LONG-TERM CLINICAL RESULTS. ADDITIONAL INFORMATION RECEIVED ON 01/22/2021: ALLEGEDLY, THE PATIENT WAS REVISED DUE TO LOOSENING OF BOTH THE FEMUR AND TIBIAL COMPONENTS AS WELL AS INFECTION. ADDITIONAL INFORMATION RECEIVED ON 01/24/2021: PRIMARY OPERATION DATE IS MAR 13,2018. ADDITIONAL INFORMATION RECEIVED ON 01/27/2021: PRODUCT ID'S AND LOT NUMBERS FOR TIBIAL AND FEMUR REVISED COMPONENTS WERE OBTAINED. ADDITIONAL INFORMATION RECEIVED ON 04/29/2021: REVISION FACILITY AND SURGEON CONFIRMATION. JAPAN-OC-000000099.

  Patient problems: Unspecified Infection

  MAUDE report 11334901 ↗