Skip to content

Evolution EIS8S12LRecalls & reported problems

Microport Orthopedics Inc. · EVOLUTION® MP™ CS INSERT SIZE 8 STANDARD 12MM LEFT · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684EIS8S12L1), received between Apr 13, 2020 and Apr 13, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1

Patient problems

  • No Information1

Recent adverse event reports

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

  • MalfunctionApr 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ALLEGEDLY, WHEN THE SURGEON OPENED THE KNEE UP HE SAID THAT THE POLY HAD BECOME LOOSE AND WANTED TO KNOW THE AMOUNT OF FORCE IT WOULD TAKE TO CAUSE THIS. WHEN HE REVISED THE CASE, HE USED A 10MM POLY. COMPONENTS NOT REVISED. EVOLUTION MP FEMORAL COMPONENT EFSRN8PL 1750275; EVOLUTION MP KEELED TIBIAL BASE ETPKN8PL 1746908; ADVANCED ONLAY ALL POLY PATELLA KPONTP41 01010471651757454; ADVANCED EVOLUTION PIN PACK 3 LONG K0001288 1832553.

    Patient problems: No Information

    MAUDE report 9955014 ↗

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

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

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.