JOURNEY 74027234Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885556179161), received between Nov 8, 2018 and May 16, 2024 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA SURGERY WAS PERFORMED ON UNKNOWN DATE, THE PATIENT EXPERIENCED ARTICULAR INSERT LOOSENING. THIS ADVERSE EVENT WAS SOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 12MM WAS REMOVED AND EXCHANGED TO A 15MM INSERT SIZE 3-4. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19336031 ↗
• MalfunctionApr 5, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING TKA SURGERY, AS THE SCRUB TEAM WERE OPENING THE STERILE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 12MM, THE OUTER BOX WAS SEALED CORRECTLY AND WRAPPED IN CELLOPHANE, THE INNER BOX HOWEVER, WAS NOT GLUED DOWN CORRECTLY, ON FURTHER INSPECTION THE SECOND INNER BOX WAS ALSO NOT GLUED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 19052233 ↗
• MalfunctionDec 6, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, A JRNY II BCS XLPE ART ISRT SZ 3-4-RT 12MM DID NOT GOT FULLY SEATED TO THE BASEPLATE. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH 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 18275738 ↗
• InjuryMay 24, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AFTER A JOURNEY II BCS XLPE ARTICULAR INSERT SZ 3-4 RIGHT 12MM WAS IMPLANTED IN AN UNKNOWN DATE, THE PATIENT EXPERIENCED RANGE OF MOTION PROBLEMS; LACKING 10-15 DEGREES OF EXTENSION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. A NEW DEVICE JRNY II BCS XLPE ART ISRT SZ 3-4-RT 9MM WAS IMPLANTED. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 11871621 ↗
• MalfunctionNov 20, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING SURGERY SURGEON TRIED TO IMPLANT INSERT, BUT THE INSERT WOULD NOT SIT INTO THE TIBIAL TRAY. S&N BACKUP AVAILABLE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10877365 ↗
• InjuryMar 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY. THE INSERT WAS EXCHANGED.

  Patient problems: Injury

  MAUDE report 9857733 ↗
• InjuryFeb 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND INFECTION. THE DOCTOR SAID THAT THE DEVICES DID NOT DEFECT. HE RESOLVED PATELLA LOOSENING DUE TO INFECTION AFTER TKA SURGERY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9729955 ↗
• InjuryOct 28, 2019Unstable; Unstable

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RECURRENT EFFUSIONS AND KNEE INSTABILITY. THE INSERT WAS EXCHANGED. THE PATIENT PRESENTED AT 1 YEAR POSTOPERATIVE WITH RECURRENT PAINFUL KNEE EFFUSIONS. HE HAS HAD MULTIPLE KNEE ASPIRATIONS. HE HAS BEEN TO TREAT HIS EFFUSIONS WITHOUT SUCCESS. HE HAS BEEN RULED OUT FOR PERIPROSTHETIC JOINT INFECTION. HE HAS SIGNS OF KNEE INSTABILITY ON EXAM. HIS PATELLA WAS NOT RESURFACED AT THE ORIGINAL PROCEDURE. GIVEN HIS ONGOING PAIN AND RECURRENT SWELLING, A REVISION SURGICAL TREATMENT WAS RECOMMENDED.

  Patient problems: Injury

  MAUDE report 9247969 ↗
• InjuryOct 24, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO STIFFENING.

  Patient problems: Injury

  MAUDE report 9235257 ↗
• InjuryJun 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SECOND REVISION SURGERY WAS PERFORMED DUE TO RECURRENT INFECTION. THE INSERT WAS EXCHANGED FOR A NEW ONE AND DEBRIDEMENT WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 8743965 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SUSPECTED INFECTION. DEBRIDEMENT AND INSERT REPLACEMENT WERE PERFORMED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8051530 ↗

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