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EVOLUTION®DCF E1204108Recalls & reported problems

Microport Orthopedics Inc. · Class 1

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 M684E12041081), received between May 10, 2022 and May 10, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

  • Break1
  • Malposition of Device1

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.

  • InjuryMay 10, 2022Break; Malposition of Device; Break; Malposition of Device

    ALLEGEDLY, TURNED THE ROTATING DIAL ON CUTTING TO '0' POSITION. AT THIS POINT IT HAD MALFUNCTION DUE ANTERIOR RESECTION WAS OFF AND NOTCHED THE ANTERIOR CORTEX SIGNIFICANTLY, POSTERIOR RESECTION DID NOT ALIGN CORRECTLY. THE CUTTING BLOCK AND BACK PLATE, SPRING, AND CENTER DIAL POPPED OUT WERE REMOVED. IT WAS CONFIRMED THAT DUE TO THIS INSTRUMENT BREAKING, THE FEMORAL BONE WAS CUT INCORRECTLY LEADING TO A REVISION OF THE COMPONENTS IN SURGERY AND A 2.5 HOUR DELAY. ALSO, ONLY ONE SET OF IMPLANTS WAS USED IN THE SURGERY AND THEY WERE IMPLANTED.

    Patient problems: Insufficient Information

    MAUDE report 14348221 ↗

Other Guide, surgical, instrument devices

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