JOURNEY 74027263Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556178065), received between Oct 4, 2017 and Apr 9, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2024Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TOTAL KNEE REPLACEMENT HAD BEEN PERFORMED ON (B)(6)2019 WITH A JOURNEY II BCS SYSTEM, THE PATIENT EXPERIENCED PAIN AND INTERMITTENT SWELLING. THERE WAS A MODERATE BALANCE FLEXION AND EXTENSION GAP LAXITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXCHANGE THE POLY FROM 11 MM TO 15 MM CONSTRAINED.

  Patient problems: Joint Laxity; Joint effusion; Pain

  MAUDE report 19076208 ↗
• InjuryJul 19, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT FELL AND BROKE THE POST ONE (1) JRNY II BCS XLPE ART ISRT SZ 5-6 LT 11MM. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. INSERT WAS REPLACED WITH A CONSTRAINED POLY. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17347838 ↗
• InjuryOct 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2016, THE PATIENT FELT A POP IN HIS KNEE. THIS INCIDENT HAPPENED WHEN THE PATIENT STARTED TO STAND UP AFTER BEING IN A DEEP SEATED POSITION, AFTER THIS THE PATIENT WAS UNABLE TO FLEX HIS KNEE PAST 30 DEG. THIS ISSUE WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2022, IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 5-6 LT 11MM WAS FOUND BROKEN OFF. THE PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 15535754 ↗
• InjuryMay 4, 2022Adverse 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 WITH A JOURNEY II BCS SYSTEM ON (B)(6) 2022, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2022 TO EXCHANGE THE JRNY II BCS XLPE ART ISRT SZ 5-6 LT 11MM. CURRENT PATIENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14279578 ↗
• InjuryDec 28, 2020Break; Break

  IT WAS REPORTED THAT, THERE WAS A POST BROKE ON A JOURNEY II BCS XLPE ART INSERT SIZE 5-6 LEFT 11MM. INCIDENT OCCURRED WHILE PATIENT WAS PAINTING (KNEELING AND WALKING ON HIS KNEES). THERE WAS A POLY SWAP. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 11077532 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT BECAME UNSTABLE AFTER A WELL FUNCTIONING KNEE THAT WAS ESTIMATED TO BE PUT IN APPROXIMATELY 8-10 YEARS AGO. THE INSERT WAS REMOVED AND UPSIZED TO ACHIEVE THE DESIRED STABILITY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 10788187 ↗
• InjuryNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UNSPECIFIED REASONS.

  Patient problems: Injury

  MAUDE report 9313359 ↗
• InjuryMar 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO INFECTION AND PAIN. NO ADDITIONAL DETAILS REPORTED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8458307 ↗
• InjuryMar 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS REPORTED DUE TO INFECTION AND PAIN.

  Patient problems: Unspecified Infection

  MAUDE report 8458269 ↗
• InjuryDec 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PARTIAL REVISION OF LEFT TKA, I&D POLYETHYLENE INSERT WAS PERFORMED DUE TO LACERATION/DEEP PERI-PROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7077430 ↗
• InjuryOct 4, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO DO A POLY SWAP AND SYNOVECTOMY. THE PATELLA CAME OUT EASY WHEN SURGEON TESTED IT WITH AN OSTEOTOME.

  Patient problems: Injury; No Information

  MAUDE report 6913584 ↗

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-0157-2024 · Sep 27, 2023 · Open, Classified
  JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis
• 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