JOURNEY 74022127Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885556170519), received between Jul 21, 2017 and Jun 7, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE CLINICAL SUBJECT EXPERIENCED AN ATRAUMATIC PATELLA FRACTURE OF THE LEFT KNEE ON (B)(6) 2025, AFTER UNDERGOING A SECONDARY PATELLA REPLACEMENT. THIS ADVERSE EVENT HAS NOT BEEN TREATED AND HAS NOT BEEN RESOLVED.

  Patient problems: Bone Fracture(s)

  MAUDE report 25422721 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED, THE PATIENT REQUIRED A REVISION TO IMPROVE PATELLAR TRACKING. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH A JRNY II BCS FEMORAL OXIN LT SZ 7, JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM AND A JOURNEY TIBIA BASE NP LT SZ 5 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23937498 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT TKA NAVIO ASSISTED SURGERY ON (B)(6) 2020, DUE TO ARTHRITIS AND IN WHICH JOURNEY II BCS SMITH & NEPHEW COMPONENT(S) WERE IMPLANTED, PATIENT SUSTAINED STIFFNESS. THIS EVENT WAS TREATED WITH MANIPULATION UNDER ANESTHESIA (MUA) ON (B)(6) 2020. THIS CONDITION MIGHT HAVE BEEN EXACERBATED DUE TO AS MISSED PHYSICAL THERAPY CONSEQUENCE OF COVID. 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: Loss of Range of Motion

  MAUDE report 21540309 ↗
• InjuryJun 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER APPROXIMATELY 5 YEARS AFTER A TKA PERFORMED ON (B)(6) 2016, IT WAS NOTICED ON AN X-RAY THAT THERE WAS LOW PATELLAR TILT AND LATERALIZATION OF PATELLA. INVESTIGATOR ASSESSED AS POSSIBLY RELATED TO DEVICE AND PROCEDURE, AND NO TREATMENT AT THIS TIME AND THE CASE IS ONGOING.

  Patient problems: Pain

  MAUDE report 12075317 ↗
• InjuryMay 18, 2020Adverse 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, THE PATIENT DEVELOPED AN INFECTION. THE EVENT WAS RESOLVED BY PERFORMING A REVISION SURGERY: THE JOURNEY II BCS FEMORAL COMPONENT WAS EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Bacterial Infection; Impaired Healing; Insufficient Information; Unspecified Infection

  MAUDE report 10065123 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTS PATELLOFEMORAL PAIN. LOW PATELLAR TILT AND LATERALIZATION OF PATELLA. A PROCEDURE WAS PERFORMED TO TREAT THE ADVERSE EVENT.

  Patient problems: Pain

  MAUDE report 9881291 ↗
• InjuryDec 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Injury

  MAUDE report 9482539 ↗
• InjuryMay 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A MANIPULATION UNDER ANESTHESIA DUE TO THE KNEE IS BARELY AT 60° OF FLEXION AND THE PATIENT CERTAINLY LACKS THE LAST 15 OR SO DEGREES OF EXTENSION. INTENSIFYING PHYSIOTHERAPY AND REHABILITATION IS FAILING TO MAKE ANY SIGNIFICANT OR MEANINGFUL PROGRESS.

  Patient problems: Injury

  MAUDE report 8643564 ↗
• 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 8458294 ↗
• InjuryMar 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8454209 ↗
• InjuryMar 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  REMAINING LOSS OF FUNCTION AND LIMITED FLEXION AND EXTENSION AFTER TKA LEFT. SUBJECT WAS HOSPITALISED AND UNDERWENT MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8395339 ↗
• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT SUFFERED FROM DERMATITIS SINCE TWO WEEKS AFTER THE KNEE REPLACEMENT ON BOTH LEGS. PATIENT IS WILLING TO OBTAIN A METAL ALLERGY TEST (MELISA TESTING) FROM A MEDICAL INSTITUTE IN (B)(6). PATIENT HAS RECEIVED MULTIPLE DUPIXENT INJECTIONS, ONCE EVERY TWO WEEKS SINCE (B)(6) 2017 FOR RASH AND ITCHING.

  Patient problems: Skin Irritation

  MAUDE report 7519027 ↗
• InjuryDec 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO A SUBLUXED DISLOCATED LEFT PATELLA.

  Patient problems: Joint Dislocation

  MAUDE report 7137535 ↗
• InjuryNov 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT PRESENTED WITH FLEXION CONTRACTURE AND UNDERWENT A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 7069956 ↗
• InjuryNov 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IRRIGATION AND A DEBRIDEMENT WITH POLYETHYLENE EXCHANGE IN THE LEFT KNEE DUE TO LEFT KNEE ARTHROFIBROSIS AND INFECTION. THE TIBIAL INSERT COMPONENT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 7016341 ↗
• InjuryJul 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION KNEE SURGERY WAS PERFORMED DUE TO PAIN. THE PATELLA WAS RESURFACED DURING THE REVISION SURGERY.

  Patient problems: Pain

  MAUDE report 6732111 ↗

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