Evolution EIS5S12LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684EIS5S12L1), received between Mar 24, 2022 and Jul 7, 2025 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2025Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT L TKR ON (B)(6) 2023. REVISED ON (B)(6) 2025 DUE TO INSTABILITY. TIBIAL INSERT CHANGED FROM 12MM TO 17MM. AUSTRALIA-C25-157.

  Patient problems: Insufficient Information

  MAUDE report 22414494 ↗
• InjuryJan 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SADE 17K001 - PATIENT # (B)(6). ALLEGEDLY, SUBJECT (B)(6) HAD A REVISION SURGERY AT MICHIGAN MEDICINE BY DR. HALLSTROM ON (B)(6) 2022. THE OFFICE NOTE ON (B)(6) 2022 STATES "WORK UP FOR INFECTION WAS NEGATIVE. IMPLANT MAY BE LOOSE. DUE TO HER SYMPTOMS, WORSENING PAIN, AND LIMITED FUNCTION, SHE IS A CANDIDATE FOR REVISION OF HER KNEE REPLACEMENT." PER NOTE, SUBJECT WANTED TO PROCEED WITH REVISION SURGERY.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 21242575 ↗
• InjuryJun 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  SAE-17K001 - PATIENT (B)(6) . ALLEGEDLY, PATIENT HAD PRIMARY SURGERY ON (B)(6) 2021 ON LEFT KNEE. THIS IS A POST OP COMPLAINT ON (B)(6) 2022. PES ANSERINUS BURSITIS/PAIN OF LEFT KNEE. NO REVISION AT THIS POINT, PAIN IS ONGOING/RESOLVED. NO FURTHER DETAILS AVAILABLE.

  Patient problems: Inflammation; Pain

  MAUDE report 19449656 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  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 13871861 ↗