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Evolution EIP4S12RRecalls & reported problems

Microport Orthopedics Inc. · EVOLUTION® MP™ PS INSERT SIZE 4 STANDARD 12MM RIGHT · Class 2 · Implant

Data updated Oct 13, 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 M684EIP4S12R1), received between Dec 1, 2021 and Dec 1, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Mechanical Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryDec 1, 2021Mechanical Problem; Mechanical Problem

    ALLEGEDLY, DURING OPERATION, INSERT CANNOT BE ASSEMBLED. SURGEON CHANGED A THICKER ONE TO CONTINUE. IT'S SUSPECTED BY THE SURGEON THE FAILURE WAS CAUSED DUE TO THE INSERT. SURGERY EXTENDED MORE THAN 30 MINUTES.

    Patient problems: Insufficient Information

    MAUDE report 12908592 ↗

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices

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Sources and updates

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