JOURNEY 71461015Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010544223), received between Dec 17, 2018 and Apr 7, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

1 other recall cover devices cleared under the same FDA submission (K051086, K093056, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A RIGHT PATELLOFEMORAL SURGERY WAS PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED INCREASE IN PAIN. X-RAYS WERE PERFORMED ON (B)(6) 2023 AND THEY WERE UNREMARKABLE. HOWEVER, ON (B)(6) 2023 X-RAYS REVEALED THERE WAS A VISIBLE FRACTURE OF THE TROCHLEA AND A POSTERIOR RUPTURE ON THE SURFACE OF THE JOURNEY PF IMPLANT MED RT. THIS EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH THE FRACTURED FEMORAL COMPONENT WAS REMOVED. PATIENT'S HEALTH STATUS IS GOOD. REPLACEMENT OPERATION WENT WELL.

  Patient problems: Failure of Implant

  MAUDE report 19057131 ↗
• InjuryOct 10, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A CONVENTIONAL PATELLOFEMORAL PROSTHESIS AND PATELLA FROM ANOTHER SUPPLIER HAD BEEN IMPLANTED ON (B)(6) 2021, THE PATIENT EXPERIENCED PURIFORM ASEPTIC EFFUSION, SEVERE PAIN AND FUNCTIONAL DIFFICULTIES A FEW MONTHS LATER, THEREFORE, ALLERGY TEST REVEALED ALLERGIES TO CHROMIUM, COBALT, NICKEL AND, TO A LESSER EXTENT, IRON AND MANGANESE (NO ALLERGIES TO CEMENT, TITANIUM, ZIRCONIUM OR NIOBIUM WERE FOUND). AS A CONSEQUENCE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 IN WHICH THE COMPETITOR DEVICE WAS EXPLANTED AND A JOURNEY PF IMPLANT MED RT WAS IMPLANTED. ADDITIONALLY, PROGRESS APPEARED FAVORABLE UNTIL A MECHANICAL FALL FIVE MONTHS LATER RESULTED IN PROFUSE EFFUSION, HOWEVER, THE RADIOLOGICAL EXAMINATION REVEALED NO ABNORMALITIES IN IMPLANT POSITIONING OR FIXATION. AFTER RULING OUT SEPTIC ARTHRITIS, THE DIAGNOSIS OF ALLERGY WAS ADOPTED. FURTHERMORE, IT IS SUSPECTED A RELEASE OF CHROMIUM OR NICKEL METAL IONS. THE PATIENT HAD UNDERGONE CORTICOSTEROID INFILTRATION PRIOR TO IMPLANT REPLACEMENT AFTER INFECTION MANAGEMENT. THE RESULT WAS FAVORABLE FOR THE EFFUSION, BUT NOT VERY LONG-LASTING. THE PATIENT SHOWED DISCRETE IMPROVEMENT DESPITE A STILL ABUNDANT EFF

  Patient problems: Arthralgia; Fall; High metal ion levels; Hypersensitivity/Allergic reaction; Joint effusion

  MAUDE report 17907274 ↗
• InjuryAug 13, 2021Crack; Crack

  IT WAS REPORTED THAT, AFTER PFJ RECONSTRUCTION SURGERY HAD BEEN PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED PAIN IN THE RIGHT KNEE AFTER A FALL. THIS ADVERSE EVENT WAS SOLVED BY CONVERTING TO TKR ON (B)(6) 2021. IT WAS NOTICED THAT THE JOURNEY PF IMPLANT MED RT WAS CRACKED AND THE GEN II 7.5MM RESUR PAT 32MM WAS ERODED. PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: Arthralgia; Failure of Implant

  MAUDE report 12320890 ↗
• InjuryDec 17, 2018Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR A REPLACEMENT OF THE PARTIAL ENDOPROSTHESIS DUE TO A PROGRESSION OF OSTEOARTHRITIS IN THE RIGHT KNEE. IT WAS DISCOVERED THE COMPONENT WAS BROKEN.

  Patient problems: Injury

  MAUDE report 8172067 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051086, K093056, 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