JOURNEY 74021268Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556615294), received between Mar 16, 2021 and Sep 8, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON THE (B)(6) 2018, THE PATIENT EXPERIENCED LOOSENING ON THE OPERATED KNEE. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022 TO THREAD THIS ADVERSE EVENT. THE PATIENT OUTCOME IS RESOLVED.

  Patient problems: Joint Laxity

  MAUDE report 15380520 ↗
• InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA, AN IRRIGATION AND DEBRIDEMENT TREATMENT WAS REQUIRED DUE TO AN OPENED WOUND ON LEFT KNEE (1.5 X 1.5 CM WOUND , NEAR VARICOSE VEIN). THE WOUND WAS OVER THE LOCATION OF A LARGE VARICOSE VEIN PATIENT HAD THAT WAS COAGULATED DURING SURGERY, IT WAS VERY SUPERFICIAL AND PROBABLY PLACED THE AREA IN A RISK OF WOUND HEALING. IT SEEMED LIKE THE PATIENT HAD FAT NECROSIS OF THE AREA AND SLIGHT CELLULITIS. THE TREATMENT CONSISTED OF SHARPING AND EXCISIONAL DEBRIDEMENT OF LEFT KNEE DOWN TO PRE-PATELLAR FASCIA, FOLLOWED BY THE ASPIRATION OF LEFT KNEE, A PULSAVAC LAVAGE OF THE WOUND, LOCAL TISSUE RE-ARRANGEMENT FOR TOTAL WOUND AND FLAP AREA OF 8 X 5 CM AND THE APPLICATION OF A NEGATIVE PRESSURE WOUND THERAPY. FOUR DEVICES WERE ASSOCIATED WITH THIS EVENT: JRNY II CR FEM COCR NP LT SZ 8, JOURNEY TIBIA BASE NP LT SZ 7, JRNY II ISRT XLPE DD LT SZ 7-8 9MM AND GII OVAL RESURFACING PAT 35MM. HOWEVER, IT IS UNKNOWN HOW THEY FAILED. NO OTHER COMPLICATIONS WERE REPORTED. NO DEVICE WAS EXPLANTED DURING IRRIGATION AND DEBRIDEMENT. OR FLUID CULTURE RESULTS WERE NEGATIVE GROWTH, SUPERFICIAL TISSUE SKIN CULTURES AS EXPECTED WITH SKIN FLORA; THEREFORE, NO INFECTION WAS CONFIRMED

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 11496053 ↗