JOURNEY 74021154Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556422854), received between Dec 15, 2017 and Sep 15, 2024 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY WAS PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED METALLOSIS. THIS ADVERSE EVENT WAS RESOLVED VIA REVISION SURGERY ON (B)(6) 2024 IN WHICH DEFORMATION OF THE JRNY II CR FEM OX NP RT SZ 4 AND THE JRNY II CR ISRT XLPE RT SZ 1-2 9MM WERE NOTICED, AS WELL AS NECROTIC TISSUE. ALL COMPONENTS WERE REPLACED FOR ZIMMER REVISION IMPLANTS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Metal Related Pathology

  MAUDE report 20220969 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED PAIN AND PATELLA DISLOCATION. PATELLA TRACKING DISORDER WAS NOTED FROM THE PRIMARY SURGERY. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A JRNY II CR FEM OX NP RT SZ 4, JOURNEY TIBIA BASE NP RT SZ 3 AND JRNY II CR ISRT XLPE RT SZ 3-4 11MM WERE EXCHANGED TO COMPETITOR PRODUCTS. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 18527132 ↗
• MalfunctionDec 6, 2023Delivered as Unsterile Product; Incomplete or Missing Packaging; Delivered as Unsterile Product; Incomplete or Missing Packaging

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT THE PACKAGING INSIDE THE BOX WAS UNSTERILE, AS THE LID ON THE INNER PLASTIC PACKAGING OF A JRNY II CR FEM OX NP RT SZ 4 WAS MISSING. FURTHERMORE, IN THE PICTURE PROVIDED, IT APPEARS THAT THE TRAY IS MISSING A SEAL TRANSFER ON THE CORNER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278539 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY OF THE RIGHT KNEE THAT HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN STARTING ON (B)(6) 2022. THIS ADVERSE EVENT LEAD TO THE HOSPITALIZATION OF THE PATIENT BETWEEN THE DATES OF (B)(6) 2022 THROUGH (B)(6) 2022, BY WHICH POINT IT WAS CONSIDERED SOLVED; EVEN THEN, THERE WERE NO REPORTED TREATMENTS DONE ON THE PATIENT. THE PATIENT'S CURRENT HEALTH STATUS HAS BEEN REPORTED AS RECOVERED.

  Patient problems: Pain

  MAUDE report 17743867 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY, HAD BEEN PERFORMED ON (B)(6) 2018, PATIENT EXPERIENCED MECHANICAL FAILURE OF RIGHT TOTAL KNEE ARTHROPLASTY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO ADDRESS THIS ADVERSE EVENT IN WHICH IT WAS CONFIRM THAT THE PATIENT HAD METALLOSIS THROUGHOUT THE ENTIRE KNEE, AND ALL COMPONENTS WERE EXPLANTED AND CHANGED. PATIENT IS RECOVERING.

  Patient problems: Deformity/ Disfigurement; Failure of Implant; Insufficient Information; Metal Related Pathology

  MAUDE report 16557994 ↗
• InjuryJan 3, 2023Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT TKA SURGERY WAS PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED MECHANICAL FAILURE OF THE DEVICE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A JRNY II CR FEM OX NP RT SZ 4 WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16091167 ↗
• InjuryFeb 4, 2022Adverse 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 IN (B)(6) 2017 WITH A JOURNEY II XR SYSTEM, PATIENT CELLULITIS WHILE IS LIFE-THREATENING IF NOT TREATED. TREATMENT WITH ANTIBIOTICS WAS PERFORMED TO RESOLVE THE REPORTED EVENT.

  Patient problems: Cellulitis

  MAUDE report 13458665 ↗
• InjurySep 21, 2021Adverse 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) 2017, THE PATIENT EXPERIENCED RIGHT KNEE INSTABILITY AND PATELLA SUBLUXATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION OF TIBIAL AND FEMORAL COMPONENTS ON (B)(6) 2019. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity; Subluxation

  MAUDE report 12511058 ↗
• InjuryMay 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED BY IMPLANTING A JOURNEY II SYSTEM, THE CLINICAL SUBJECT EXPERIENCED DEEP SCAR FORMATION DUE TO A FALL. THE EVENT WAS TREATED VIA PROCEDURE: SYNOVECTOMY. THE SITUATION IS CONSIDERED RESOLVED.

  Patient problems: Injury

  MAUDE report 10082455 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT DEVELOPED CELLULITIS IN THE RIGHT LOWER EXTREMITY. THE EVENT WAS TREATED VIA MEDICATION AND MEDICAL INTERVENTION TO PREVENT A LIFE-THREATENING CONDITION IN THE SUBJECT.

  Patient problems: Unspecified Infection

  MAUDE report 9832132 ↗
• InjuryMar 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAS DEEP VEIN THROMBOSIS ON THE RIGHT KNEE. THE ISSUE HAS BEEN RESOLVED WITH MEDICATION THERAPY.

  Patient problems: Swelling

  MAUDE report 8464348 ↗
• InjuryDec 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT HAS BEEN HAVING SWELLING AND A WARM SENSATION IN THE RIGHT KNEE. THE PATIENT HAS HAD A CORTISONE SHOT AND IS CURRENTLY TAKING TRAMADOL. THE PATIENT IS ALLERGIC TO NICKEL.

  Patient problems: Swelling

  MAUDE report 7122603 ↗

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