ADVANCE® K0001015Recalls & 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 M684K00010151), received between Jan 17, 2025 and Jan 17, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Mechanical Jam1
Patient problems
- Metal Related Pathology1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2025Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information
ALLEGEDLY, THE PINS WERE STUCK ONCE AGAIN INTO THE HOLE OF THE 10 MM DISTAL FEMORAL CUTTING GUIDE. WHILE TRYING TO REMOVE THE PINS, THE SURGEON ACCIDENTALLY INJURED HIS SCRUBBER WHO HAD A WOUND THAT NECESSITATED 2 STITCHES.
Patient problems: Metal Related Pathology
MAUDE report 21180768 ↗
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- ACUFEX 72204044Smith & Nephew, Inc. · BIT, SURGICAL25 reports
- NA 03.168.011Synthes GmbH · BIT, SURGICAL20 reports
- ACUFEX 72204042Smith & Nephew, Inc. · BIT, SURGICAL19 reports
- ACUFEX 72204046Smith & Nephew, Inc. · BIT, SURGICAL16 reports
- ACUFEX 72204045Smith & Nephew, Inc. · BIT, SURGICAL14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.