JOURNEY 74027262Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885556178010), received between Aug 18, 2017 and Apr 9, 2026 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 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 16, 2026.

Recalls naming this device

1. Sep 27, 2023Open, Classified

   The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

   Z-0157-2024 · Root cause: Component change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, IT WAS NOTICED THAT A JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM WAS IMPLANTED ONTO A SIZE 7 JRNY II TIBIAL BASE PLATE. THE SURGEON HAS BEEN MADE AWARE OF THE SITUATION. A REVISION SURGERY IS PLANNED TO CORRECT THE IMPLANTED INSERT; HOWEVER, THE SCHEDULED DATE IS CURRENTLY UNKNOWN. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24831564 ↗
• InjuryDec 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2024, PATIENT EXPERIENCED CAM/POST DISASSOCIATION IN DEEP FLEXION. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2025, DURING WHICH THE JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM WAS EXCHANGED. FURTHERMORE, IT WAS NOTED THAT THE POST WAS DEFORMED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23700334 ↗
• InjuryDec 27, 2024Break; Break

  IT WAS REPORTED THAT AFTER UNDERGOING A TKA ON (B)(6) 2016, PATIENT HAD A TRAUMATIC FALL AND KNEE INSTABILITY THERE AFTER. UPON MRI, IT WAS FOUND TO HAVE BROKEN XLPE INSERT POST. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, TO EXCHANGE THE JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 21029839 ↗
• InjuryMar 15, 2024Adverse 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) 2024, THE PATIENT EXPERIENCED A FEELING OF WRONGNESS. IN ADDITION, DUE TO UNKNOWN CAUSES/SYMPTOMS, THERE WAS SUSPICION OF INFECTION, FOR WHICH A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2024. DURING THIS PROCEDURE, THE PRIMARY JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 5-6 LEFT 10MM WAS EXCHANGED TO ANOTHER JOURNEY II BCS INSERT. THE FEMORAL COMPONENT, TIBIAL BASEPLATE AND PATELLAR COMPONENT REMAINED IN SITU. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 18915617 ↗
• MalfunctionSep 29, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT INSIDE A JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM BOX WAS A CONSTRAINED INSERT INSTEAD OF THE CORRECT ONE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843959 ↗
• InjuryMay 18, 2020Adverse 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, THE PATIENT DEVELOPED AN INFECTION. THE EVENT WAS RESOLVED BY PERFORMING A REVISION SURGERY: THE JOURNEY II INSERT WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 10065337 ↗
• InjuryApr 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD KNEE EFFUSION AND REQUIRED AN ASPIRATION.

  Patient problems: Aspiration/Inhalation; Injury

  MAUDE report 8518973 ↗
• InjuryApr 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT LEFT KNEE ARTHROFIBROSIS. TREATMENT: ASPIRATION AND CLOSED MANIPULATION.

  Patient problems: Fibrosis

  MAUDE report 8493788 ↗
• InjuryMar 14, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SEVERE PAIN ALONG WITH SNAPPING AND GRINDING OVER THE ANTEROLATERAL ASPECT OF THE KNEE.

  Patient problems: Pain

  MAUDE report 8420936 ↗
• InjuryMar 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  REMAINING LOSS OF FUNCTION AND LIMITED FLEXION AND EXTENSION AFTER TKA LEFT. SUBJECT WAS HOSPITALISED AND UNDERWENT MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8395583 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO PAIN IN THE KNEE. NO EVIDENCE OF INFECTION WAS FOUND. LAXITY OF THE COMPONENTS WAS PRESENT MOST NOTABLY IN FULL FLEXION. FEMORAL, TIBIAL AND ARTICULAR DEVICES WERE EXPLANTED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7924880 ↗
• InjurySep 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD LEFT TKA ANKYLOSIS AND EVENT WAS RESOLVED IN CLOSED MANIPULATION UNDER ANESTHESIA FOR WHICH SUBJECT WAS HOSPITALIZED.

  Patient problems: Injury

  MAUDE report 7912603 ↗
• InjurySep 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TWO STEP REVISION SURGERY WAS PERFORMED DUE TO A PERI-PROSTHETIC JOINT INFECTION IN LEFT KNEE. IN FIRST STEP OF THE REVISION SURGERY, ON (B)(6) 2017, PATELLAR COMPONENT AND ARTICULAR INSERT WERE EXPLANTED AND AN ANTIBIOTIC SPACER WAS IMPLANTED. AND ON (B)(6) 2017 THE TOTAL KNEE WAS REVISED TO PERFORM A REIMPLANTATION OF DEVICES.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7891868 ↗
• InjuryAug 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED KNEE. THE POLY WAS REMOVED FROM THE PATIENT, WAS WASHED OUT AND A NEW POLY WAS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 7834916 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRESENTED WITH FLEXION CONTRACTURE AND UNDERWENT A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 7069957 ↗
• InjuryAug 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT PRESENTED WITH LEFT KNEE PAIN AND SWELLING DURING SECOND WEEK POST OP LEFT TKA. THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT W/ LINER EXCHANGE.

  Patient problems: Hematoma; Pain

  MAUDE report 6805674 ↗

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-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