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Evolution ETPKN2PLRecalls & reported problems

Microport Orthopedics Inc. · EVOLUTION® MP TIB KEELED NONPOR SIZE 2+ LEFT · 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 M684ETPKN2PL1), received between Nov 7, 2022 and Nov 7, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Packaging 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Packaging 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.

  • InjuryNov 7, 2022Packaging Problem; Packaging Problem

    ALLEGEDLY, DURING THE OPERATION, THE DOCTOR OPENED THE BOX OF PRODUCT " ETPKN2PL, LOT-1916559", BUT ACTUALLY THE PRODUCT INSIDE THE BOX IS "ETPKN7SL, LOT-1916715". ONCE BEING AWARE OF THE INCIDENT, THE DOCTOR SWITCHED TO ANOTHER PRODUCT (ETPKN2PL, LOT.1928701) IMMEDIATELY. THE OPERATION WAS COMPLETED FINALLY. ADDITIONAL INFORMATION RECEIVED ON 10/27/2022: THIS INCIDENT DELAYED THE SURGERY BY 30 MINUTES. DOMESTIC AE REPORT NUMBER REFERENCE: (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 15743440 ↗

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Sources and updates

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