JOURNEY 74025651Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556422465), received between Jun 30, 2018 and Apr 18, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A DAIR (DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION) PROCEDURE AND A POLY EXCHANGE ON (B)(6) 2026. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Wound Infection

  MAUDE report 24919492 ↗
• InjuryAug 25, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED SEPTIC LOOSENING OF IMPLANTS. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022 TO EXCHANGE THE FOLLOWING DEVICES: JRNY II CR FEM OX NP RT SZ 7, JOURNEY TIBIA BASE NP RT SZ 6 AND JRNY II CR ISRT XLPE RT SZ 5-6 9MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 15294150 ↗
• InjuryJul 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AND TREATED WITH HEPARIN DUE TO DEEP VEIN THROMBOSIS.

  Patient problems: Injury

  MAUDE report 8796504 ↗
• InjuryJul 2, 2018Mechanical Problem; Device Issue; Mechanical Problem; Device Issue

  IT WAS REPORTED THAT AFTER IMPLANTING THE FEMUR AND TIBIA, SURGEON PUT IN THE POLY. ONCE IN PLACE, HE COULD NOT GET THE POLY TO ADVANCE POSTERIORLY AND LOCK IN TO PLACE. MULTIPLE ATTEMPTS AND SAME RESULT WITH SUBSEQUENT POLYS. THERE WAS A CONSISTENT DEFORMATION ON THE POSTERIOR MEDIAL PORTION OF THE USED POLYS. MULTIPLE CHECK WERE MADE TO ENSURE THE POSTERIOR ASPECT OF THE TIBIA TRAY WAS CLEAR OF ANY TISSUE OR POSSIBLE CEMENT. FINALLY WAS ABLE TO GET THE 4 POLY TO ENGAGE AFTER TRIMMING SOME OF THE DEFORMED PLASTIC WITH A SURGICAL INSTRUMENT. THE SURGICAL TIME WAS EXTENDED FOR APPROXIMATELY 1 HOUR.

  Patient problems: Injury; No Information

  MAUDE report 7657159 ↗
• InjuryJun 30, 2018Loose or Intermittent Connection; Mechanical Problem; Loose or Intermittent Connection; Mechanical Problem

  IT WAS REPORTED THAT AFTER IMPLANTING THE FEMUR AND TIBIA, SURGEON PUT IN THE POLY. ONCE IN PLACE, HE COULD NOT GET THE POLY TO ADVANCE POSTERIORLY AND LOCK IN TO PLACE. MULTIPLE ATTEMPTS AND SAME RESULT WITH SUBSEQUENT POLYS. THERE WAS A CONSISTENT DEFORMATION ON THE POSTERIOR MEDIAL PORTION OF THE USED POLYS. MULTIPLE CHECK WERE MADE TO ENSURE THE POSTERIOR ASPECT OF THE TIBIA TRAY WAS CLEAR OF ANY TISSUE OR POSSIBLE CEMENT. FINALLY WAS ABLE TO GET THE 4 POLY TO ENGAGE AFTER TRIMMING SOME OF THE DEFORMED PLASTIC WITH A SURGICAL INSTRUMENT. THE SURGICAL TIME WAS EXTENDED FOR APPROXIMATELY 1 HOUR.

  Patient problems: Injury; No Information

  MAUDE report 7653699 ↗

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