Evolution EIS5S14LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684EIS5S14L1), received between Jul 13, 2020 and Mar 2, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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. 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.

• 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: Joint Laxity

  MAUDE report 11400151 ↗
• InjuryFeb 24, 2021Break; Naturally Worn; Break; Naturally Worn

  ALLEGEDLY, FIRST OPERATION AT (B)(6) IN 2017. VISITED (B)(6) ON SUSPICION OF INFECTION. IT WILL BE REMOVED FOR INFECTION ON (B)(6) 2020 AND (B)(6) 2021. DURING THE OPERATION ON (B)(6) 2021, HIS TIBIAL BASE WAS CLEARLY DAMAGED WHEN REMOVED. PHYSICIAN'S FINDINGS: SINCE THERE ARE NO FINDINGS OF METALLOSIS, IT IS UNLIKELY THAT THE IMPLANT HAD BEEN DAMAGED FIRST, BUT I AM WORRIED THAT THE IMPLANT MAY BE EASILY DAMAGED. REPORTER'S FINDINGS AND RESPONSE STATUS; IT SEEMS THAT THE SCAFFOLDING WAS LOST DUE TO THE INFLUENCE OF THE INFECTION AND IT WAS DAMAGED. HOWEVER, BECAUSE THERE ARE MANY RELATED FACILITIES, WE WOULD LIKE TO CONFIRM THAT THE IMPLANT MEETS OUR SAFETY STANDARDS. (B)(4). ADDITIONAL INFORMATION RECEIVED ON 02/05/2021 FROM RELIABILITY ENGINEER: ADDING NEW PRODUCTS TO THE GROUP WITH ITS CORRESPONDING CODES.

  Patient problems: Unspecified Infection

  MAUDE report 11371804 ↗
• InjuryJul 13, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. THE SIZE 5 14MM TIBIAL INSERT WAS REMOVED AND REPLACED WITH A 24MM THICK INSERT. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10268484 ↗