JOURNEY 74022214Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 03596010554284), received between Oct 10, 2017 and Apr 21, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 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. 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED IN 2013, THE PATIENT EXPERIENCED LOOSENING. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH A JOURNEY TIBIA BASE NP RT SZ 4 AND THE JOURN ART INS BCS STD 3-4 RT11 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Aseptic loosening

  MAUDE report 24940255 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA NAVIO ASSISTED SURGERY ON (B)(6) 2019, DUE TO DEGENERATIVE JOINT DISEASE AND IN WHICH JOURNEY II BCS SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED, PATIENT SUSTAINED A NONDISPLACED PERIPROSTHETIC TIBIA FRACTURE ON (B)(6) 2020 THAT HEAL UNEVENTFULLY BUT WITH PERSISTENT PAIN THROUGHOUT THE TWO YEARS FOLLOW-UP. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. THIS INFORMATION WAS COLLECTED RETROSPECTIVELY AS PART OF A POST-MARKET CLINICAL FOLLOW UP ACTIVITY AND IS PROVIDED IN AN ANONYMIZED FORMAT; THEREFORE, NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Arthralgia; Periprosthetic fracture

  MAUDE report 21537684 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH RIGHT MEDIAL LIGAMENT LAXITY. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 12857574 ↗
• InjuryOct 16, 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 PAIN AND INFECTION. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE IMPLANTS, ALTHOUGH THE SURGEON STATED THAT IMPLANTS WERE NOT DEFECTIVE. IT IS UNKNOWN IF EVENT WAS RESOLVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10689485 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON JULY 7, 2020 A JII RIGHT SIDE TIBIAL BASEPLATE WAS IMPLANTED IN A PATIENT UNDERGOING A LEFT SIDE TKA DUE TO AN USER ERROR. IT IS UNKNOWN IF THERE WAS A DELAY. THE PATIENT IS DOING WELL. THERE IS ANY SCHEDULED REVISION SURGERY FOR THE PATIENT YET. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10365679 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CLINICAL SUBJECT WAS HOSPITALIZED DUE TO A FALL. THE PATIENT SUFFERED FROM WOUND DEHISCENCE DUE TO THE FALL AND SPENT 10 DAYS IN THE HOSPITAL.

  Patient problems: Injury

  MAUDE report 9832145 ↗
• InjurySep 6, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT PRESENTED A RIGHT FOOT FRACTURE. ADVERSE EVENT HAS A POSSIBLE RELATION TO DEVICE. NO PROCEDURE DETAILS REPORTED. EVENT WAS RESOLVED WITH CONSERVATIVE APPROACH.

  Patient problems: Injury

  MAUDE report 8969388 ↗
• InjuryAug 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A FALL WITH WOUND DEHISCENCE.

  Patient problems: Injury

  MAUDE report 8892471 ↗
• InjuryAug 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND TREATED WITH ELIQUIS DUE TO LOWER EXTREMITY DEEP VEIN THROMBOSIS.

  Patient problems: Swelling

  MAUDE report 8886074 ↗
• InjuryAug 7, 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 8868027 ↗
• InjuryAug 7, 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 8868015 ↗
• InjuryJul 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS WITH DECREASED RANGE OF MOTION AND KNEE PAIN. MANIPULATION UNDER ANESTHESIA WAS PERFORMED ON (B)(6) 2018 TO RESOLVE THIS ISSUE.

  Patient problems: Fibrosis

  MAUDE report 8834721 ↗
• InjuryApr 21, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT PATIENT HAD PERSISTENT STIFFNESS IN RIGHT KNEE AFTER SURGERY. FOR THIS EVENT SUBJECT UNDERWENT MOBILISATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8534371 ↗
• InjuryApr 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD ATRIAL FIBRILLATION WHICH WAS TREATED WITH MEDICATION AND HOSPITALISATION WAS PROLONGED.

  Patient problems: Injury

  MAUDE report 8534367 ↗
• InjuryApr 15, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  POST-OPERATIVE LIMITED RANGE OF MOTION (70°) RIGHT KNEE AFTER TKA SURGERY. SUBJECT WAS HOSPITALISED. EVENT REPRESENTS A SERIOUS ADVERSE DEVICE EFFECT.

  Patient problems: Injury

  MAUDE report 8512704 ↗
• InjuryMar 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED IN A STUDY THAT THE PATIENT HAD CELLULITIS AS A RESULT OF LYMPHANGITIS OVER THE ANTEROLATERAL ASPECT OF THE PROXIMAL TIBIA. THE KNEE WAS REPORTED AS WARM AND HYPERSENSITIVE; PATIENT ADMITTED TO HOSPITAL FOR IV ANTIBIOTIC REGIME TO TREAT. THE EVENT WAS ASSESSED BY THE REPORTER AS RELATED TO THE STUDY PROCEDURE AND THE POSSIBILITY OF THE DEVICE CAUSING OR CONTRIBUTING TO THE EVENT COULD NOT BE EXCLUDED.

  Patient problems: Unspecified Infection

  MAUDE report 8457057 ↗
• InjuryJan 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SUBJECT ID: (B)(4). IT WAS REPORTED THAT THE PATIENT HAS A RIGHT KNEE BURSITIS. THE CAUSE OF THE BURSA INFLAMMATION IS UNKNOWN. ALSO IS UNKNOWN IF ANY IMPLANT HAS BEEN EXPLANTED TO THE PATIENT OR TREATMENT FOR THE BURSA INFLAMMATION.

  Patient problems: Injury; Joint Swelling

  MAUDE report 8217717 ↗
• InjurySep 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Injury

  MAUDE report 7899703 ↗
• 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 RIGHT KNEE ARTHROSCOPIC SYNOVECTOMY AND HYPERTROPHIC SCAR REMOVAL.

  Patient problems: Injury

  MAUDE report 7337821 ↗
• InjuryFeb 26, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED A REVISION SURGERY DUE TO RADIOLUCENCY IN TIBIA. METALLOSIS AND LOOSE TIBIAL BASE PLATE WAS IDENTIFIED . FEMUR WAS FOUND SOLID BUT REPLACED SINCE NO TIBIAL COMPONENT WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 7298274 ↗
• InjuryJan 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ASPIRATION OF THE RIGHT KNEE WAS PERFORMED DUE TO INFECTION AND INFLAMMATION REACTION.

  Patient problems: Unspecified Infection

  MAUDE report 7206140 ↗
• InjuryJan 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD RIGHT KNEE SWELLING AND STIFFNESS, RESOLVED WITH MANIPULATION UNDER ANESTHESIA; MODERATE RIGHT KNEE EFFUSION WITH NO DRAINAGE; AND RIGHT KNEE PAIN WORSENING WITH A STEROID INJECTION ORDERED.

  Patient problems: Joint Swelling

  MAUDE report 7160902 ↗
• InjuryDec 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A KNEE ASPIRATION WAS PERFORMED DUE TO INCREASED SWELLING WITH HEMATOMA.

  Patient problems: Swelling

  MAUDE report 7134957 ↗
• InjuryNov 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION INDICATED THE PATIENT WAS READMITTED (B)(6) 2015 FOR A MANIPULATION UNDER ANESTHESIA. THE PATIENT ALSO PRESENTED WITH SWELLING OF THE RIGHT KNEE ON (B)(6) 2016 HOWEVER NO TREATMENT WAS PROVIDED.

  Patient problems: Loss of Range of Motion

  MAUDE report 7069541 ↗
• InjuryNov 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON THE RIGHT KNEE FOR PATELLAR COMPONENT AND POLY EXCHANGE DUE TO KNEE PAIN, LEG PAIN, ASSOCIATED SWELLING AND LOOSENING OF INTERNAL PROSTHESIS RIGHT KNEE.

  Patient problems: Joint Swelling

  MAUDE report 7035675 ↗

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