Evolution EIS5S10LRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI M684EIS5S10L1), received between Nov 20, 2019 and Jul 18, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Unstable” (5 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 12 most recent of 12 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. C24-282 AUSTRALIA.

  Patient problems: Pain

  MAUDE report 19774130 ↗
• 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

  Patient problems: Pain

  MAUDE report 19586695 ↗
• InjuryDec 14, 2022Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT L TKR ON (B)(6) 2022 . REVISED ON (B)(6) 2022 DUE TO INSTABILITY. 10MM INSERT REPLACED WITH 14MM. (B)(6).

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

  MAUDE report 15979084 ↗
• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(4). SIDE: L. PRIMARY ASA: P2: MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED: EVOLUTION MP FEM CS/CR NON-POR PRIMARY SZ 5 LEFT PRODUCT ID: EFSRN5PL LOT NO.: 1757661 EVOLUTION MP KEELED TIBIA BASE SIZE 5 LEFT PRIMARY CEMENTED PRODUCT ID: ETPKN5SL LOT NO.: 1757056. MHRA REFERENCE NO: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 12037007 ↗
• InjuryMay 13, 2021Fracture

  ALLEGEDLY, PATIENT FRACTURED HER PATELLA, ON REPAIRING THE BONE AN INFECTION WAS CAUSED. (B)(6). ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR ON 04/27/2021: ALLEGEDLY, THE PATELLA WAS NOT REVISED, PROXIMAL EDGE OF PATELLA FRACTURED FROM A TRAUMA PROSPECTIVE, ABOVE THE IMPLANTED POLY RESURFACED PATELLA.

  Patient problems: Unspecified Infection

  MAUDE report 11820342 ↗
• InjuryApr 21, 2021Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, THE TIBIAL INSERT WAS REVISED DUE TO INFECTION, AS STATED BY THE SURGEON. THERE WERE NO KNOWN ISSUES WITH THE ORIGINAL SURGERY, OR IMPLANT ALIGNMENT. THE POLY SWAP WAS COMPLETED WITHOUT INCIDENT. (B)(6) REFERENCE NO: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11703496 ↗
• InjuryMar 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT LEFT TKR ON (B)(6) 2018. PATELLA RESURFACED ON (B)(6) 2019 AND INSERT REPLACED FROM 10MM TO 14MM, REASON UNKNOWN. NO FURTHER INFORMATION AVAILABLE. (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 11436843 ↗
• InjuryDec 29, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT LEFT TKR ON (B)(6) 2020. REVISED ON (B)(6) 2020 DUE TO INSTABILITY. TIBIAL INSERT CHANGED FROM 10MM TO 14MM. (B)(6).

  Patient problems: No Information

  MAUDE report 11089962 ↗
• InjuryAug 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO FEMORAL COMPONENT OVERSIZED AND THE PATIENT MOTION WAS QUITE LIMITED, WITH A RANGE OF 0 TO 30 DEGREES , WITH A HARD STOP AT 30 DEGREES.

  Patient problems: Loss of Range of Motion

  MAUDE report 10420874 ↗
• InjuryJun 24, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY AND PROGRESSIVE ARTHRITIS. COMPONENTS NOT REVISED: EVOLUTION MP FEM CS/CR NON-POR PRIMARY SZ 5 LEFT PRODUCT ID: EFSRN5PL LOT ID: 1601185. EVOLUTION MP KEELED TIBIA BASE SIZE 5 LEFT PRIMARY CEMENTED PRODUCT ID: ETPKN5SL LOT ID: 1601405. REVISION NJR NUMBER: 4393337. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Arthritis

  MAUDE report 10191935 ↗
• InjuryMar 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Unspecified Infection

  MAUDE report 9904171 ↗
• InjuryNov 20, 2019Unstable

  ALLEGEDLY, INSTABILITY. THE DOCTOR REMOVED THE POLY AND REPLACED IT WITH A 17MM. ONE WAS WASTED.

  Patient problems: No Information

  MAUDE report 9350839 ↗