JOURNEY 74027236Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885556179260), received between Dec 20, 2017 and May 2, 2024 — classified as 4 injuries, 2 malfunctions.

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

4 other recalls cover devices cleared under the same FDA submission (K111711, K230653); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE PACKAGE OF THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 15MM WAS NOT PROPERLY SEALED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19227983 ↗
• MalfunctionJun 22, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A JOURNEY II BCS XLPE ART ISRT SIZE 3-4-RT 15 MM CASE (B)(4) WAS NOT ABLE TO BE FULLY SEAT INTO JOURNEY TIBIA BASEPLATE NP RT SZ 3 CASE (B)(4), A 0.5 MM GAP BETWEEN THE BASEPLATE WAS LEFT AND TWO DENTS ON ANTERIOR SIDE OF INSERT WERE DEFORMED BY INSERTER. SURGERY WAS COMPLETED WITH THE SAME DEVICES BECAUSE THERE WAS NO SPARE DEVICES AVAILABLE. THIS PROBLEM CAUSED A LESS THAN 30 MIN SURGERY DELAY. PATIENT WAS REPORTED TO BE HARMED BUT IT IS UNKNOWN HOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038852 ↗
• InjuryApr 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, A JRNY II BCS XLPE ART ISRT SZ 3-4-RT 15MM WAS REMOVED AND REPLACED DUE TO PATIENT FALL. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY ON (B)(6) 2021. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 11722108 ↗
• InjuryApr 14, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  POST-OPERATIVE LIMITED RANGE OF MOTION (70°) RIGHT KNEE AFTER TKA SURGERY. SUBJECT WAS HOSPITALISED. EVENT REPRESENTS A SERIOUS ADVERSE DEVICE EFFECT.

  Patient problems: Injury

  MAUDE report 8512697 ↗
• InjuryJan 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SUPERFICIAL INFECTION. INSERT AND PATELLAR COMPONENT WERE REPLACED. THE SURGEON DOES NOT BLAME THE PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 8218063 ↗
• InjuryDec 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A KNEE ASPIRATION WAS PERFORMED DUE TO INCREASED SWELLING WITH HEMATOMA.

  Patient problems: Swelling

  MAUDE report 7134930 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111711, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0158-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
• Z-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
• Z-1099-2022 · Apr 19, 2022 · Terminated
  LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5