JOURNEY 74021157Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556422823), received between Jul 26, 2018 and Apr 4, 2023 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K121443, 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 16, 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.

• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, THE PATIENT EXPERIENCED POST-OP STIFFNESS DUE TO SCAR TISSUE ARTHROFIBROSIS. THIS ADVERSE EVENT WAS TREATED WITH AN UNSPECIFIED SURGERY OR PROCEDURE. THE CLINICAL OUTCOME OF THE PATIENT WAS REPORTED AS RECOVERED.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 16678659 ↗
• InjuryAug 25, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED SEPTIC LOOSENING OF IMPLANTS. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE FOLLOWING DEVICES: JRNY II CR FEM OX NP RT SZ 7, JOURNEY TIBIA BASE NP RT SZ 6 AND JRNY II CR ISRT XLPE RT SZ 5-6 9MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 15294133 ↗
• InjuryNov 3, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2016, A REVISION SURGERY HAD TO BE CONDUCTED ON (B)(6) 2021 DUE TO LOOSENING OF POLY. THERE WAS VISIBLE DAMAGE TO THE FEMORAL COMPONENT. THE SURGEON DECIDED THAT A COMPLETE REVISION WAS NECESSARY. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 12746844 ↗
• InjuryApr 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS RECEIVING MANIPULATION UNDER ANESTHESIA, BECAUSE OF A RIGHT KNEE ARTHROFIBROSIS. THE TREATMENT IS ONGOING.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 11616772 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: JOURNEY II CR RETRO, SUBJECT ID: SCS-0078, AE#: 1. IT WAS REPORTED THAT PATIENT PRESENTED A RIGHT KNEE INCISION INFECTION. EVENT WAS RESOLVED WITH THE PRESCRIPTION OF ANTIBIOTICS AND A WITH A REVISION SURGERY FOR A POLY LINER EXCHANGE.

  Patient problems: Unspecified Infection

  MAUDE report 10662643 ↗
• InjuryMay 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AFTER A TKA SURGERY HAD BEEN PERFORMED IN WHICH A JOURNEY II CR FEMORAL COMPONENT WAS IMPLANTED, THE CLINICAL SUBJECT PRESENTED STIFFNESS IN THE RIGHT KNEE. IT CANNOT BE EXCLUDED THAT THE ADVERSE EVENT IS LINKED TO THE SURGERY. THE EVENT WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 10043923 ↗
• InjuryNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO STIFFNESS. THE PATELLA WAS NOT REPLACED.

  Patient problems: Injury

  MAUDE report 9313379 ↗
• InjuryAug 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED THE FOLLOWING SYMPTOMS POST OPERATIVELY: RIGHT POPLITEAL TENDONITIS; RIGHT POSTEROLATERAL KNEE SOFT TISSUE IMPINGEMENT. IT WAS RESOLVED WITH UNSPECIFIED SURGICAL PROCEDURE.

  Patient problems: Injury

  MAUDE report 8897946 ↗
• 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 8868036 ↗
• InjuryJun 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A CLOSED MEDICAL MANIPULATION UNDER ANESTHESIA, DUE TO ARTHROFIBROSIS IN THE RIGHT KNEE.

  Patient problems: Injury

  MAUDE report 8712730 ↗
• InjuryJan 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A RIGHT KNEE MANIPULATION WAS PERFORMED DUE TO THE PATIENT PRESENTED LIMITED RANGE OF MOTION.

  Patient problems: Injury

  MAUDE report 8292214 ↗
• InjuryAug 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS IN THE RIGHT KNEE. EVENT TREATMENT INCLUDED SURGERY/PROCEDURE.

  Patient problems: Injury

  MAUDE report 7805394 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED DUE TO STIFFNESS.

  Patient problems: No Code Available

  MAUDE report 7721440 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121443, 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