Skip to content

JOURNEY 71436151Recalls & reported problems

Smith & Nephew, Inc. · JOURNEY UNI TIBIA BASE TRIAL SIZE 1 RIGHT MEDIAL/LEFT LATERAL · Class 2

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 03596010588180), received between Nov 6, 2020 and Nov 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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

  • Manufacturing, Packaging or Shipping Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionNov 6, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    IT WAS REPORTED THAT AFTER UNPACKING, IT WAS FOUND THAT THERE WAS NO ENGRAVED MODEL INFORMATION ON THE JOURNEY UNI TIBIAL BASE TRIAL SZ 1 RM/LL. THERE WAS NO CASE INVOLVED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10805839 ↗

Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices

All PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices →

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