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PROFIX 71524240Recalls & reported problems

Smith & Nephew, Inc. · PROFIX NON-POROUS TIB BASE L S4 · Class 2 · Implant

All models of PROFIX (22)

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 03596010228949), received between Apr 18, 2017 and Apr 18, 2017 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • No Information1
  • Pain1

Recent adverse event reports

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

  • InjuryApr 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED A REVISION SURGERY FOR THE PROFIX KNEE WAS PERFORMED DUE TO UNSPECIFIED REASONS.

    Patient problems: No Information; Pain

    MAUDE report 6501027 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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