JOURNEY 74027283Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885556178416), received between Nov 29, 2017 and Mar 25, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A FALL RESULTING IN A RUPTURED QUADRICEPS TENDON AND JOINT INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY A QUADRICEPS TENDON REPAIR ON (B)(6) 2026, IN WHICH THE SURGICAL TEAM ALSO CONVERTED THE JRNY II BCS XLPE ART ISRT SZ 7-8 LT 11MM TO A CONSTRAINED LINER. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity; Muscle/Tendon Damage

  MAUDE report 24690667 ↗
• InjuryMay 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED INSTABILITY, DURING SURGERY IT WAS NOTICED THAT THE INSERT IS BROKEN. THIS ADVERSE EVENT WAS RESOLVED BY REVISION SURGERY IN WHICH THE INSERT WAS EXCHANGED FOR AN 11 MM CONSTRAINED INSERT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 19376861 ↗
• InjuryMar 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER LEFT TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT WAS EXPERIENCING PAIN AND SWELLING IN THE LEFT KNEE. WHILE BENDING OVER THE BED OF HIS TRUCK, TRYING TO GET SOMETHING OUT, THE PATIENT HAD HIS KNEES LOCKED AND WHEN HE TRIED TO PULL BACK, HE FELT SOMETHING POP IN HIS LEFT KNEE. SINCE THAT TIME, HE FELT LIKE SOMETHING WAS FLOATING AROUND AND GETTING STUCK IN THE KNEE. THIS ADVERSE EVENT WAS SOLVED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024 IN WHICH IT WAS FOUND THAT THE POST ON THE JRNY II BCS XLPE ART INSERT SZ 7-8 LT 11MM HAD FRACTURED OFF. DURING THIS PROCEDURE, ONLY THE POLYETHYLENE INSERT WAS EXPLANTED, WHICH WAS REPLACED WITH A NEW JOURNEY II SIZE 12MM INSERT. THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 18856664 ↗
• InjuryOct 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2017 A PATIENT HAD A TKA, A JRNY II BCS XLPE ART ISRT SZ 7-8 LT 11MM WAS IMPLANTED, THE PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2022 FOR POLY REVISION, DURING REVISION SURGERY, THE POLY POST HAD BROKEN OFF IN SITU. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 15635617 ↗
• InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA ON (B)(6) 2017, THE PATIENT EXPERIENCED LEFT KNEE PAIN. THIS ADVERSE EVENT RESULTED IN A REVISION SURGERY WHERE A JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8 (CASE - (B)(4)) AND A JRNY II BCS XLPE ART ISRT SZ 7-8 LT 11MM (CASE - (B)(4)) WERE EXPLANTED. THIS WAS TREATED ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Implant Pain

  MAUDE report 12076334 ↗
• InjuryMay 6, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE LEFT JOURNEY II BCS KNEE INSERT IMPLANTED ON (B)(6) 2014 BROKE WHILE THE PATIENT KNELT DOWN. THERE IS AN SCHEDULE REVISION SURGERY TO EXPLANT THE INSERT ON (B)(6) 2021. ANY OTHER DETAILS ABOUT THE EVENT AND THE REVISION SURGERY ARE UNKNOWN.

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

  MAUDE report 11783855 ↗
• InjuryMay 20, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A 11MM JOURNEY II BCS INSERT WAS USED. WHEN THE GASKET WAS IMPLANTED, IT COULD NOT BE LOCKED FIRMLY DUE TO LOCKING REASONS. A BIGGER SIZE INSERT WAS USED TO COMPLETE THE SURGERY. NO ADDITIONAL CUTS WERE MADE FOR THE NEW SIZE INSERT. THERE WAS A DELAY OF 10 MIN. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10077578 ↗
• InjuryNov 29, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PATIENT PRESENTED WITH MEDIO-LATERAL INSTABILITY. THE PATIENT UNDERWENT A REVISION SURGERY TO EXCHANGE THE INSERT.

  Patient problems: Failure of Implant; Injury; Joint Disorder

  MAUDE report 7067738 ↗

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