JOURNEY 74027244Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556177761), received between Aug 22, 2018 and Apr 28, 2026 — classified as 8 injuries, 1 malfunction.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED IT ISSUE AND SOME INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) JRNY II BCS XLPE ART ISRT SZ 3-4 LT 12MM WAS EXPLANTED. ALSO, SOME SCARE TISSUE WAS REMOVED AND IMPLANTED 12 LT CONSTRAINED POLY. CURRENT HEALTH STATUS OF PATIENT.

  Patient problems: Joint Laxity

  MAUDE report 25016896 ↗
• InjuryMar 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A RECENT FALL AND HAS FELT INSTABILITY SINCE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2026, IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 12MM WAS EXCHANGED. IMPLANTED A THICKER POLY, AND A CONSTRAINED COMPONENT WAS USED TO GIVE HER A BETTER STABILITY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fall; Joint Laxity

  MAUDE report 24542280 ↗
• InjuryMar 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON(B)(6) 2023, IN WHICH A JRNY II BCS XLPE ART ISRT SZ 3-4 LT 12MM WAS EXCHANGED TO JOURNEY II BCS INSERT. THE JRNY II BCS FEMORAL OXIN LT SZ 4, JOURNEY TIBIA BASE NP LT SZ 3 AND GEN II 7.5MM RESUR PAT 29MM WERE NOT EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16483386 ↗
• InjuryMay 21, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING TKA, THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 12MM WAS TOO LOOSE ONCE POSITIONED AND AS PER THE SURGEON REPORT THE DEVICE DID NOT MATCH WITH THE TRIAL THAT WAS USED DURING THE PLANNING AND SIZE CHOOSING PART OF THE SURGERY. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW 15MM INSERT. A DELAY OF LESS THAN OR EQUAL TO 30 MINUTES WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863086 ↗
• InjuryFeb 24, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DUE TO AN INFECTION A REVISION SURGERY WAS PERFORMED TO REMOVE FEMORAL COMPONENT, TIBIAL BASE, TIBIAL INSERT AND PATELLAR COMPONENT.

  Patient problems: Pain

  MAUDE report 8364837 ↗
• InjuryDec 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DEBILITY AND ANTERIOR KNEE PAIN. INSERT WAS EXPLANTED. PATELLA WAS IMPLANTED.

  Patient problems: Injury

  MAUDE report 8196446 ↗
• InjuryOct 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN THE PATIENT DUE TO INCREASED LAXITY PRODUCT OF FALLING. A PATELLAR COMPONENT WAS IMPLANTED. THE INSERT WAS EXPLANTED.

  Patient problems: Injury

  MAUDE report 7931209 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO THE PATIENT AS SHE DEVELOPED ARTHROFIBROSIS.

  Patient problems: No Code Available

  MAUDE report 7927915 ↗
• MalfunctionAug 22, 2018Connection Problem; Connection Problem

  IT WAS REPORTED A MALFUNCTION DURING TKA PROCEDURE WHERE THERE WAS 45 MINUTES DELAY. THE 12MM INSERT COULD NOT BE LOCKED INTO BASE PLATE (B)(4). INSERTION WAS REPEATEDLY TRIED. FINALLY, BACK-UP 13MM INSERT WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7806185 ↗

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