JOURNEY 74025611Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00885556422748), received between Feb 2, 2018 and Aug 14, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Adverse 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 ON (B)(6) 2024, THE PATIENT EXPERIENCED WEAKNESS OF THE LIGAMENT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE JRNY II CR ISRT XLPE RT SZ 1-2 9MM WAS EXPLANTED, AND REPLACED WITH A JII MEDIAL DISHED XLPE SZ 1-2. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Damage to Ligament(s)

  MAUDE report 22811733 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA PERFORMED FOUR YEARS AGO (UNKNOWN DATE), THE PATIENT STARTED TO LOOSE MOTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH A JRNY II CR ISRT XLPE RT SZ 1-2 9MM WAS SWAPPED AND SCAR TISSUE WAS REMOVED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Loss of Range of Motion

  MAUDE report 19980323 ↗
• MalfunctionMay 12, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT THE INNER PACKAGING OF THE JRNY II CR ISRT XLPE RT SZ 1-2 9MM WAS COMPROMISED AND NOT PROPERLY SEALED AS DESIGNED FOR STERILITY. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924968 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A TKA REVISION SURGERY WAS PERFORMED FOR SUSPECTED TUMOR, IN ADDITION IT WAS FOUND DURING SURGERY THAT THE INSERT, THE BASE PLATE AND THE FEMORAL COMPONENT HAD SEVERE DAMAGE AND METALLOSIS. THE PRIMARY TKA WAS PERFORMED 4 YEARS EARLIER. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Metal Related Pathology; Solid Tumor

  MAUDE report 12164287 ↗
• InjuryJul 24, 2020Incomplete or Missing Packaging; Packaging Problem; Device Fell; Incomplete or Missing Packaging

  IT WAS REPORTED THAT DURING TKA SURGERY, UPON OPENING IMPLANT BOX, THE JOURNEY II CR INSERT XLPE RIGHT SIZE 1-2 9MM FELL FROM THE BOX BECAUSE THE STERILE WRAP WAS UNDONE. AN EQUIVALENT IMPLANT WAS AVAILABLE TO BE USED. SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 10323924 ↗
• InjuryJul 16, 2020Unsealed Device Packaging; Incomplete or Missing Packaging; Unsealed Device Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT DURING TKA SURGERY, UPON OPENING IMPLANT BOX, THE JOURNEY II CR INSERT XLPE RIGHT SIZE 1-2 9MM FELL FROM THE BOX, THIS OCCURRED BECAUSE THE STERILE WRAP WAS UNDONE. A SECOND JOURNEY II CR INSERT XLPE RIGHT SIZE 1-2 9MM WAS AVAILABLE AND AFTER OPENED THE IMPLANT BOX, AND UPON LOOKING IN, IT COULD CLEARLY SEE THAT THE IMPLANT WAS NOT PACKAGED. THE SURGEON HAD TO USE AN IMPLANT OF DIFFERENT SIZE FROM THE ORIGINALLY PLANNED. THE PROCEDURE WAS FINISHED WITH A SURGICLA DELAY OF LESS THAN 30 MINUTES WITH NO INJURY TO PATIENT.

  Patient problems: Failure of Implant; Injury; Insufficient Information; No Information

  MAUDE report 10284023 ↗
• InjuryMar 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ARTHROFIBROSIS OF THE RIGHT KNEE. THE EVENT WAS RESOLVED VIA MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 9842153 ↗
• InjuryJul 31, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT PATIENT HAD RIGHT KNEE PAIN AND STIFFNESS AND IT WAS RESOLVED WITH A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8845180 ↗
• InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO ARTHROFIBROSIS ON THE RIGHT KNEE.

  Patient problems: Injury

  MAUDE report 8727656 ↗
• InjuryFeb 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PATIENT PAIN. DURING REVISION SURGERY, IT WAS CONFIRMED THAT THE INSERT WAS DISASSOCIATED FROM A BASEPLATE.

  Patient problems: Injury; Pain

  MAUDE report 7238789 ↗

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