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PROFEMUR® PRNEPLUGRecalls & 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 M684PRNEPLUG1), received between Aug 11, 2019 and Aug 11, 2019 — 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

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.

  • InjuryAug 11, 2019Break; Break

    ALLEGEDLY DURING DR. (B)(6) ATTEMPTS AT REMOVING A BROKEN NECK THE REMNANT EXTRACTION PLUG BROKE. IT WAS AFTER THE TAPPING STAGE, DURING THE EXTRACTION STEP THAT THIS INSTRUMENT BROKE IN CONJUNCTION WITH THE NECK EXTRACTOR (CORK SCREW). FORCE WAS APPLIED TO THE NECK EXTRACTOR AND THE PLUG BROKE AT THE POINT IT WAS DECIDED TO REMOVE THE STEM WHEN THE NEW REMNANT COULD NOT BE REMOVED. (LINKED TO COMPLAINT (B)(4)). KIT NUMBER: PRNEKIT2. LOT NUMBER: 07.

    Patient problems: No Information

    MAUDE report 8881882 ↗

Other EXTRACTOR devices

All EXTRACTOR devices →

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