JOURNEY 74036106Recalls & reported problems
Smith & Nephew, Inc. · LEFT MEDIAL/RIGHT LATERAL TIBIA RESECTION GUIDE STANDARD · Class 1
All models of JOURNEY (566)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556696354), received between Nov 18, 2021 and Jan 28, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Periprosthetic fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER UKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, APPROXIMATELY 2 WEEKS AFTER THE PRIMARY SURGERY, X-RAYS SHOWED A TIBIAL FRACTURE IN THE HOLE WHERE THE LM/RL TIBIA ALIGNMENT GUIDE RETENTION PIN WAS INSERTED. THIS ADVERSE EVENT WAS TREATED BY ADDITIONAL SURGERY TO IMPLANT A PLATE ON (B)(6) 2025. THE SURGEON BELIEVES THAT THE LOCATION OF THE PIN HOLE ASSOCIATED WITH THE USE OF THE DEVICE CAUSED THE FRACTURE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Periprosthetic fracture
MAUDE report 21252174 ↗MalfunctionNov 18, 2021Break; Break
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, PINS GOT COLD-WELDED IN SLOTS ON LM/RL TIBIA RESECTION GUIDE STANDARD AND BROKE OFF. INCIDENT OCCURRED OUTSIDE THE PATIENT, AND NO PIECES FELL INTO THE INCISION. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12836257 ↗
Other Guide, surgical, instrument devices
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- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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