Evolution EIS5P10LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684EIS5P10L1), received between Apr 28, 2020 and Aug 10, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2022Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT UNDERWENT LEFT TKR ON (B)(6) 2022. REVISED ON (B)(6) 2022 DUE TO INFECTION. WASHOUT PERFORMED AND LINER CHANGED. (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15199311 ↗
• InjurySep 23, 2021Naturally Worn; Naturally Worn

  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. ADDITIONAL INFORMATION RECEIVED ON 09/02/2021: COMPONENT EIS5P10L ADDED REPORTING RESULTANT WEAR. (B)(6). BASG REF.: (B)(4).

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Loss of Range of Motion

  MAUDE report 12520518 ↗
• MalfunctionApr 28, 2020Difficult to Insert; Difficult to Insert; Device Slipped

  ALLEGEDLY, TIBIA INSERT WOULD NOT LOCK ON TIBIA TRAY. THIS WAS REPEATED THREE TIMES AND INSERT CAME OUT AFTER ALL ATTEMPTS.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 10005329 ↗