JOURNEY 74018903Recalls & reported problems
Smith & Nephew, Inc. · JOURNEY II CR LOCKING FEMORAL IMPACTOR BUMPER · Class 1
All models of JOURNEY (566)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556697979), received between Sep 21, 2020 and Dec 19, 2022 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation2
- Break1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE JII CR LOCKING FEM IMPACTOR BUMPER BROKE ON IMPACTION. ALL PIECES WERE REMOVED SUCCESSFULLY AND DEVICE WAS DISCARDED BY HOSPITAL STAFF. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16008509 ↗MalfunctionJul 5, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, JII CR LOCKING FEM IMPACTOR BUMPER IS CHIPPED. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12118534 ↗MalfunctionJul 5, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT, JII CR LOCKING FEM IMPACTOR BUMPER IS CHIPPED. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12118356 ↗InjurySep 21, 2020Break; Break
IT WAS REPORTED THAT DURING SURGERY, WHILE IMPACTING THE FEMORAL COMPONENT, THE PLASTIC IMPACTOR BROKE. PROCEDURE CONCLUDED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT A DELAY OR AN INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10558621 ↗
Other PROBE devices
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- MOSS 275010140Depuy Spine, LLC · PROBE28 reports
- EXPEDIUM 279702040Depuy Spine, LLC · PROBE21 reports
- MULTILOC 03.019.029Synthes GmbH · PROBE15 reports
- MOSS 275010160Depuy Spine, LLC · PROBE11 reports
- EXPEDIUM 279702010Depuy Spine, LLC · PROBE9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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