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Evolution EIS3S12RRecalls & reported problems

Microport Orthopedics Inc. · EVOLUTION® MP™ CS INSERT SIZE 3 STANDARD 12MM RIGHT · Class 2 · Implant

All models of Evolution (125)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684EIS3S12R1), received between Mar 30, 2022 and Mar 30, 2022 — classified as 1 injury.

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

Device problems

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 30, 2022Appropriate Device Problem Term/Code Not Available

    ALLEGEDLY, INSERT REPLACEMENT DUE TO SUSPECTED INFECTION EIS3S14R CS TIBIAL INSERT REPLACED WITH SIZE 3 14MM RIGHT FROM EIS3S12R EVOLUTION® MP CS INSERT SIZE 3 STANDARD 12MM RIGHT. (B)(6).

    Patient problems: Unspecified Infection

    MAUDE report 13956950 ↗

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Sources and updates

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