JOURNEY 74025661Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556422397), received between Aug 6, 2019 and Nov 28, 2022 — classified as 5 injuries, 2 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A JOURNEY TKA SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED INSTABILITY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A JRNY II CR ISRT XLPE LT SZ 5-6 9MM WAS EXPLANTED AND A JRNY II ISRT XLPE DD LT SZ 5-6 12MM WAS IMPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Laxity

  MAUDE report 15870234 ↗
• MalfunctionFeb 2, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED DURING INSPECTION PRIOR TO A TOTAL KNEE ARTHROPLASTY PROCEDURE, TWO JOURNEY II CR ISRT XLPE LEFT SIZE 5-6 9MM HAD HOLES IN THE PACKAGING MAKING THE POLYS UNUSABLE. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269521 ↗
• MalfunctionFeb 2, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED DURING INSPECTION PRIOR TO A TOTAL KNEE ARTHROPLASTY PROCEDURE, TWO JOURNEY II CR ISRT XLPE LEFT SIZE 5-6 9MM HAD HOLES IN THE PACKAGING MAKING THE POLYS UNUSABLE. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269498 ↗
• 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 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 10503114 ↗
• 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 10474385 ↗
• 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 9255860 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO PULMONARY EMBOLISM. AND TREATED WITH AN UNKNOWN REMEDIAL THERAPY.

  Patient problems: Injury

  MAUDE report 8867776 ↗

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