Skip to content

PROFIX 71507261Recalls & reported problems

Smith & Nephew, Inc. · PROFIX CONFORMING TIBIAL INSERT LEFT SIZE 6 10MM · Class 2 · Implant

All models of PROFIX (22)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010220509), received between Aug 9, 2018 and Aug 9, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 Information2

Patient problems

  • Pain2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RIGHT KNEE LOOSENING AND LEFT KNEE PAIN.

    Patient problems: Pain

    MAUDE report 7768120 ↗
  • InjuryAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RIGHT KNEE LOOSENING AND LEFT KNEE PAIN.

    Patient problems: Pain

    MAUDE report 7767336 ↗

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

How reports and recalls are matched · Editorial policy · Report an error on this page