Skip to content

VORTEX 71272001Recalls & reported problems

Smith & Nephew, Inc. · VORTEX CEMENT GUN · Class 1

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 03596010515018), received between Sep 17, 2019 and Sep 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective 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

  • Defective Component1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionSep 17, 2019Defective Component; Defective Component

    IT WAS REPORTED THAT, DURING SURGERY, THE CEMENT GUN DID NOT PROGRESS FORWARD HANDLE STICKS. SURGEON HAD TO PUSH CEMENT OUT BY HAND. THERE WAS A TWO MINUTE PROCEDURAL DELAY. THERE WAS NO SMITH & NEPHEW AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9079868 ↗

Other DISPENSER, CEMENT devices

All DISPENSER, CEMENT devices →

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