JOURNEY 74022224Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03596010554321), received between May 18, 2017 and Dec 1, 2024 — classified as 26 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 reports).

4 other recalls cover devices cleared under the same FDA submission (K042515, K091014, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2024, THE PATIENT SUFFERED A BONE FRACTURE DUE TO A FALL. A REVISION SURGERY WAS PERFORMED IN ORDER TO EXCHANGE THE JOURNEY TIBIA BASE NP LT SZ 4, THAT WAS NOTICED TO BE LOOSE, AND THE JRNY II BCS XLPE ART ISRT SZ 3-4 LT 9MM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Failure of Implant; Fall

  MAUDE report 20815523 ↗
• InjuryJun 14, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, SIX MONTHS AFTER A JOURNEY II SYSTEM HAD BEEN IMPLANTED, THE PATIENT PRESENTED A PAINFUL AND PERSISTENT LOCAL INFLAMMATORY SYNDROME. FURTHER INFORMATION HAS NOT BEEN PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17132256 ↗
• MalfunctionJun 18, 2022Problem with Sterilization; Problem with Sterilization

  IT WAS REPORTED THAT, DURING TKA SURGERY, WHEN THE JOURNEY TIBIA BASE NP LT SZ 4 BOX WAS OPENED, IT WAS NOTICED A WARPED STERILE PACKAGE; THEREFORE, COULD NOT TRUST STERILITY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739801 ↗
• MalfunctionJun 18, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A TKA SURGERY WHEN THE BOX OF THE JOURNEY TIBIA BASE NP LT SZ 4 WAS OPENED, THE STERILE PACKAGING WAS DAMAGED, IT LOOKED LIKE A STERILIZATION OR OVER HEATING ISSUE. THE OUTER PACKAGING LOOKED FINE. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT SURGICAL DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14739792 ↗
• InjurySep 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. A REVISION SURGERY WAS PERFORMED TO TREAT IT: THE JOURNEY TIBIA BASE NP LEFT SIZE 4 WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 10526113 ↗
• InjuryJul 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUFFER FROM AN ACUTE RENAL FAILURE ON (B)(6) 2018 REQUIRING PROLONGED HOSPITALIZATION. RESOLVED (B)(6) 2018 AND DISCHARGED HOME ON (B)(6) 2018. EVENT WAS CONFIRMED BY LABORATORY DATA THROUGH BASIC METABOLIC PANEL. EVENT WAS TREATED WITH MEDICATION. ALSO, PATIENT PRESENTED CONFUSION 4 DAYS AFTER SURGERY, THE OUTCOME IS RESOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10335996 ↗
• InjuryNov 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A STITCH ABCESS IN THE DISTAL END OF HER LEFT KNEE INCISION. IT WAS TREATED WITH ANTIBIOTICS AND SURGERY FOR INCISION AND DRAINAGE. THE WOUND HAD DELAYED HEALING WITH CONTINUED ANTIBIOTICS AND BETADINE TREATMENTS.

  Patient problems: Injury

  MAUDE report 9281436 ↗
• InjuryJul 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE ARTHROFIBROSIS.

  Patient problems: Fibrosis

  MAUDE report 8834732 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD LEFT KNEE ARTHROFIBROSIS AND REQUIRED MANIPULATION UNDER ANESTHESIA AND ASPIRATION.

  Patient problems: Fibrosis

  MAUDE report 8834602 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD CELULLITIS IN LEFT LEG AND A SURGICAL PROCEDURE WAS REQUIRED TO RESOLVE IT.

  Patient problems: Cellulitis

  MAUDE report 8834597 ↗
• InjuryJul 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 8830701 ↗
• InjuryApr 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  JOURNEY II BCS RETRO STUDY; SUBJECT: UZL-0192; AE#01. IT WAS REPORTED THAT PATIENT HAD AN INFECTION TKA LEFT FOR WHICH A REVISION SURGERY WAS REQUIRED.

  Patient problems: Unspecified Infection

  MAUDE report 8547229 ↗
• InjuryFeb 22, 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 8364599 ↗
• InjuryJan 25, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT HAS COMPONENTS IN PLACE SINCE (B)(6) 2015 AND WAS EXPERIENCING PAIN, DURING A REVISION SURGERY PROCEDURE IT WAS FOUND THAT TIBIA WAS LOOSE. CEMENT WAS WELL-ADHERED TO THE TIBIA BASE PLATE, BUT WAS LOOSE FROM THE BONE.

  Patient problems: Injury

  MAUDE report 8278336 ↗
• InjuryDec 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED ON THE PATIENT DUE TO INCREASED PAIN AND REDUCED RANGE OF MOTION. NO INSTABILITY IDENTIFIED, PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: Injury

  MAUDE report 8197592 ↗
• InjuryDec 24, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE TIBIAL BASEPLATE.

  Patient problems: Injury

  MAUDE report 8194119 ↗
• InjuryOct 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE POOR RANGE OF MOTION AND EXPERIENCING MORE PAIN THAN EXPECTED. AN ASPIRATION WAS PERFORMED TO RULE OUT INFECTION.

  Patient problems: Aspiration/Inhalation; Loss of Range of Motion; Pain

  MAUDE report 7929012 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Fibrosis

  MAUDE report 7924162 ↗
• InjurySep 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LEFT KNEE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7882915 ↗
• InjuryAug 6, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PATIENT'S IMPLANT HAS CAUSED THE PATIENT A LOT OF PAIN AND PROSTHETIC JOINT MECHANICAL FAILURE. PATIENT IS WAITING ON APPOINTMENT FOR REVISION SURGERY TO REMOVE ALL DEVICES.

  Patient problems: Injury

  MAUDE report 7754766 ↗
• InjuryJun 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL PROCEDURE IS SCHEDULED FOR EXAMINATION UNDER ANESTHESIC, ARTHROSCOPY AND ARTHROSCOPIC ARTHROLYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7561338 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED FOR ARTHROSCOPIC ABRASION OF CICATRIX.

  Patient problems: Injury

  MAUDE report 7338804 ↗
• InjuryMar 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS NEEDED TO PERFORM A JOINT EFFUSION OF THE LEFT KNEE.

  Patient problems: No Information

  MAUDE report 7313356 ↗
• InjuryFeb 28, 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 LOOSENED COMPONENT.

  Patient problems: Failure of Implant

  MAUDE report 7302901 ↗
• InjuryFeb 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INTERNALLY ROTATED TIBIA.

  Patient problems: Injury; Pain

  MAUDE report 7287796 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042515, K091014, K230653. One submission often covers many models, so check the product and lot details in each record.

• 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-0002-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 7402112
• Z-0001-2019 · Jun 13, 2018 · Open, Classified
  Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 7
• Z-0003-2019 · Jun 13, 2018 · Open, Classified
  JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 7402312