JOURNEY 74022227Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010554406), received between Nov 10, 2017 and Nov 4, 2020 — classified as 13 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 (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2020Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER AN IMPLANTATION PROCEDURE OF A JOURNEY TIBIA BASE NP LT SZ 7, THE PATIENT PRESENTED A CHROME INTOXICATION.

  Patient problems: Infiltration into Tissue; Toxemia

  MAUDE report 10789254 ↗
• 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 9881318 ↗
• InjuryMar 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY, LEFT TKR, THE PATIENT SUFFERED FROM DISCOMFORT AND REPETITIVE BLEEDING EPISODES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9795131 ↗
• InjuryJul 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT PRESENTING A SWOLLEN KNEE AND BIOPSIES INDICATED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8814263 ↗
• InjuryMay 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A MANIPULATION UNDER ANESTHESIA DUE TO THE KNEE IS BARELY AT 60 DEGREE 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 8661090 ↗
• InjuryMar 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER UNDERWENT A TOTAL KNEE ARTHROPLASTY FOR A STUDY, THE PATIENT HAD DELAYED WOUND HEALING AND POSSIBLE INFECTION. REVISION SURGERY AND DRAINAGE WERE PERFORMED WITH A POLY EXCHANGE. THE SUBJECT RECOVERED FROM THE EVENT BUT WAS TERMINATED FROM THE STUDY. THE EXPLANTED DEVICE WAS DESTROYED.

  Patient problems: Unspecified Infection

  MAUDE report 8434687 ↗
• InjuryFeb 11, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DR. PERFORMED A LEFT KNEE REPLACEMENT ON HIS PATIENT ON THE (B)(6) 2018. SHE COMPLAINED OF PERSISTENT PAIN AND STIFFNESS AND DR. DIAGNOSED HER WITH SEVERE ARTHROFIBROSIS. HE TOOK HER BACK TO THEATRE ON (B)(6) 2019 AND REVISED THE FEMORAL COMPONENT TO ONE SIZE SMALLER AND EXCHANGED THE INSERT. NO MORE INFORMATION SHOWN.

  Patient problems: Unspecified Infection

  MAUDE report 8326958 ↗
• InjuryDec 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. PATIENT PRESENTED WITH METALLOSIS, JOINT WAS INFLAMED, SOFT TISSUE HAD A BLACK COLOUR. THE SURGEON REVISED THE KNEE, TOOK OUT THE IMPLANTS AND REPLACED THEM.

  Patient problems: Injury

  MAUDE report 8175823 ↗
• InjuryNov 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A JOURNEY I KNEE NEEDED TO BE REVISED.

  Patient problems: Injury

  MAUDE report 8036161 ↗
• 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 DECEMBER 2017 FOR RASH AND ITCHING.

  Patient problems: Skin Irritation

  MAUDE report 7519302 ↗
• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED AFTER LEFT TKA DUE TO ARTHROSCOPIC EXCISION OF HYPERTROPHIC SCAR.

  Patient problems: Injury; No Code Available

  MAUDE report 7111820 ↗
• InjuryNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT LOST RANGE OF MOTION DUE TO ARTHROFIBROSIS AFTER TKA AND UNDERGO MANIPULATION UNDER ANESTHESIA TO REGAIN ROM.

  Patient problems: Injury

  MAUDE report 7050309 ↗
• InjuryNov 10, 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 7017821 ↗

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-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
• 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