JOURNEY 74021166Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556422779), received between Jul 26, 2019 and Sep 10, 2025 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA THAT TOOK PLACE ON (B)(6) 2024, A JRNY II CR FEM OX NP LT SZ 6, A JRNY II XR INS XLPE MED 5-6 LT 8MM, A JRNY II XR INS XLPE MED 5-6 LT 8MM, A JRNY II XR BASEPLATE SZ 5 LT, AND A GNS II BICONVEX PAT 23MM WERE EXPLANTED DUE TO AN INFECTION ON A REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2025. NEW REVISION PLANNED AFTER 6 WEEKS. NO MORE INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 23016559 ↗
• MalfunctionOct 4, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE OF THE LUGS OF THE JRNY II CR FEM OX NP LT SZ 6 WAS NOTICED TO BE MISSING. THE PROCEDURE WAS PERFORMED, AFTER A SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20376173 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A SURGERY HAD BEEN PERFORMED ON (B)(6) 2019 THE PATIENT EXPERIENCED SEVERE STIFFNESS. THIS ADVERSE EVENT WAS RESOLVED BY REVISION SURGERY ON (B)(6) 2021. THE SUBJECT WAS HOSPITALIZED AND TREATMENT WAS NECESSARY TO PREVENT PERMANENT IMPAIRMENT OF KNEE FUNCTION OR KNEE STRUCTURE. THE CURRENT HEALTH STATUS OF THE PATIENT IN UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 17794323 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LEFT KNEE REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 BECAUSE OF AN INFECTION WITH ENTEROCOCCUS FAECALIS. THE FEMORAL COMPONENT, THE ARTICULAR INSERT AND THE TIBIAL BASE PLATE WERE EXPLANTED. THE INFECTION WAS TREATED WITH VANCOMYCIN AND METRONIDAZOLE. THE OUTCOME OF THE PROCEDURE IS RESOLVED, WITH RESIDUAL EFFECT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10503073 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED BECAUSE THE PATIENT DEVELOPED AN INFECTION IN THE RIGHT TKA. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10474331 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TKA PROCEDURE PATIENT HAD EPISODE OF THIRD DEGREE HEART BLOCK. HEART RATE DROPPED TO 10. THE PROCEDURE WAS STOPPED. THE CRASH CART WAS BROUGHT IN THE ROOM, AND THE CODE TEAM ACTIVATED. NO COMPRESSION REQUIRED, MEDICATION ADMINISTERED PER ANESTHESIA. HOSPITALIZATION WAS PROLONGED AS A RESULT OF THE EVENT.

  Patient problems: Heart Block; Irregular Pulse

  MAUDE report 10421081 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TKR ON (B)(6) 2018. DESPITE PHYSICAL THERAPY AND ADEQUATE PAIN MANAGEMENT, THE PATIENT WAS UNABLE TO MAINTAIN AN ACCEPTABLE POST-OP KNEE RANGE OF MOTION (KNEE STIFFNESS). MANIPULATION UNDER ANESTHESIA WAS PERFORMED TWICE. ACTIONS TAKEN WERE: SURGERY, MEDICATION THERAPY AND PHYSICAL THERAPY. THE PATIENT GAINED SIGNIFICANT ROM & WAS ABLE TO ACHIEVE MORE TERMINAL FLEXION. THE OUTCOME OF THIS EVENT IS STILL ONGOING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Pain

  MAUDE report 10356582 ↗
• 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 9/30/18 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 10335961 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED LEFT KNEE PATELLAR IMPINGEMENT AND CREPITUS. EVENT WAS TREATED WITH IRRIGATION AND DEBRIDEMENT.

  Patient problems: Injury

  MAUDE report 10014636 ↗
• InjuryApr 14, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AFTER PRIMARY SURGERY, USING JOURNEY II XR IMPLANTS PATIENT HAD KNEE STIFFNESS AND DECREASED RANGE OF MOTION. DESPITE PHYSICAL THERAPY; ADEQUATE PAIN MANAGEMENT, THE PATIENT WAS UNABLE TO MAINTAIN AN ACCEPTABLE POST OPERATIVE KNEE RANGE OF MOTION. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE EVENT. PATIENT GAINED SIGNIFICANT RANGE OF MOTION AND WAS ABLE TO ACHIEVE MORE TERMINAL FLEXION.

  Patient problems: Loss of Range of Motion

  MAUDE report 9957485 ↗
• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED CELLULITIS OF THE LEFT LOWER EXTREMITY. THE EVENT WAS TREATED VIA REMEDIAL THERAPY (DRUG/TRANSFUSION).

  Patient problems: Unspecified Infection

  MAUDE report 9255865 ↗
• 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 8830695 ↗

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